Ever since the COVID-19 vaccines were approved for the public population, conversations have persisted regarding their efficacy, especially regarding people who had immediate allergic reactions with the first dose.

Despite this, a multicenter, retrospective study confirmed that most patients with immediate and potentially 

 to the COVID-19 vaccines tolerated the 2nd dose.

In an interview with HCPLive, 2 of the leading authors of the study, Kimberly Blumenthal, MD, MSc, Quality and Safety Officer for Allergy, Massachusetts General Hospital, Co-Director, Clinical Epidemiology Program, Division of Rheumatology Allergy and Immunology and Matthew Krantz, MD, Clinical Fellow, Allergy/Immunology, Vanderbilt University Medical Center spoke of the genesis of the study as well as the data gathered on reactions from participants.

Prior to the study, the team targeted healthcare workers who had received some of the first doses of the Pfizer-BioNTech and Moderna vaccines.

“One of the unexpected observations early on after emergency use authorization in December of 2020 where we primarily targeted vaccinating healthcare workers was we did observe a higher rate of immediate potentially allergic reactions and anaphylaxis than with traditional vaccines,” Krantz said.

Krantz, Blumenthal and colleagues set out to find if participants in the study were truly allergic to the COVID-19 vaccines.

“If you're allergic to something, you have an IgE antibody, [so] you have to avoid it,” Blumenthal said. “That’s really important for mRNA vaccines: were people forming true, classic allergy to these vaccines?”

From January 1, 2021-March 31, 2021, the investigators enrolled 189 patients from participating centers, all of whom recorded an immediate reaction to their first Pfizer-BioNTech or Moderna vaccine.

Patient population demographics showed that the mean age of all patients was 43 years, and that most of the total population (86%) were women. Of the vaccine first-dose reactions, 130 (69%) were Moderna and 59 (31%) were Pfizer-BioNTech.

Allergic reactions were defined as symptom onset within 4 hours of dose 1, at least 1 allergic symptom, and referral for an allergy/immunology consultation with in-clinic or tele-heath assessment.

Anaphylaxis was scored using the Brighton and the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network Criteria.

Blumenthal, Krantz and colleagues defined second dose tolerance as 1 of the following:

1. No immediate symptoms after second dose administration

2. Symptoms that were mild, self-limited and/or resolved with antihistamines

Phone calls regarding clinical details were made for individuals who did not have their second dose observed by allergy/immunology departments.

The investigators noted that the most frequently reported first-dose reactions in patients were flushing or erythema (28%), dizziness or lightheadedness (26%), tingling (24%), throat tightness (22%), and hives (21%), and 32 participants (21%) met the anaphylaxis criteria.

Encouragingly, 159 patients as well as 19 individuals who experienced first-dose anaphylaxis tolerated the second dose of the COVID-19 vaccine. Only 20% of participants reported immediate and potentially allergic symptoms associated with the second dose, which were either self-limited, mild, or resolved with antihistamines alone.

Additionally, most of the participants in the study (89%) received the second dose, and 47 patients (30%) were given an antihistamine premedication before the second dose.

“It's important to note that in terms of classic IgE allergy, we do not expect premedications to abort a reaction,” Krantz said. “But, in the case of a non-IgE mediated reaction, antihistamines can also blunt or make these reactions (milder).”

The effectiveness of the drugs on some patients supported the hypothesis that the participants did not have to avoid the COVID-19 vaccines, as they did not have what’s considered a “classic allergy” response.

Blumenthal also noted the effectiveness of the premedication and clarified that the study was not intended to recommend a specific medication, as each patient was treated with individual methods depending on what their allergist felt was appropriate.

“Everybody had a different [recommendation],” Blumenthal said. “This study wasn't designed to test how best to get from a dose 1 immediate reaction to safe dose 2 completion. But it gives us a hint that it's largely possible.”

Blumenthal noted that further research might explore the possibilities of a specific premedication or treatment methods for patients who had a reaction to the COVID-19 vaccines, especially considering the possibilities of COVID-19 vaccine boosters in the coming fall season.

“What we really need is a prospective study when it comes to the booster doses,” Blumenthal said. “So, prospective, meaning that we enroll people who had reactions before (and) who didn't have reactions, and we have them diary their medication so that we can piece out what premedication regimen might work.”

Blumenthal and Krantz both noted the potential for improvement in identifying allergic reactions in patients regarding the COVID-19 vaccines and general vaccines. 

“Safety Evaluation of the Second Dose of Messenger RNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose,”

 was published online in JAMA Internal Medicine.

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Research showed that the second dose of the COVID-19 vaccine was well tolerated by patients who experienced allergic reactions from their first dose.

Study Shows Improved Tolerance with Second COVID-19 Vaccine

The US Food and Drug Administration (FDA) approved a New Drug Application (NDA) for intravenous (IV) selexipag (UPTRAVI) injection for adult 

 (PAH) patients with WHO functional class 2-3 who are temporarily unable to take oral therapy.

The treatment, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, will enable patients to avoid short-term treatment interruptions and stay on selexipag therapy uninterrupted.

The approval is based on the results of a prospective, multi-center, open-label single sequence cross-over phase 3 study aimed at assessing the safety, tolerability, and pharmacokinetics of temporary switching between the tablet and IV formulation of the selective prostacyclin IP receptor agonist.

In the 20 patient study, researchers found the switch between tablets and IV formulations was well tolerated with no unexpected safety findings. The adverse events found from selexipag IV was similar to what has been found in previous studies with tablets, with the exception of mild-to-moderate infusion site reactions in 2 patients that did not lead to treatment discontinuation.

Some of the treatment-related adverse events included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremities, flushing, and arthralgia.

The treatment was first approved in tablet form in 2015 to delay disease progression and reduce the risk of hospitalization for PAH.

"Given the progressive nature of this disease, maintaining treatment is important to help control PAH,” said Kelly Chin, MD, study senior author and Associate Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at The University of Texas Southwestern Medical Center, in a 

. “However, there are times where patients may be unable to take oral medications. For patients on UPTRAVI, bridging short-term temporary interruptions of UPTRAVI tablets with UPTRAVI IV may maintain the treatment effect and avoid the need to change therapy or re-titrate UPTRAVI tablets after re-initiation."

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The FDA approved selexipag tablets for PAH in 2015.

FDA Approves Selexipag IV for Pulmonary Arterial Hypertension 

A new study sheds light on the mental health burdens and care experiences among women with 

“Given the profound association of acne with quality of life, several qualitative studies have sought to understand the lived experience of acne among adolescents,” the investigators wrote.

They noted, however, that few studies have explored the lived experiences and treatment in adult populations, particularly in a large sample size.

As a result, the team, led by John Barbieri, MD, MBA, of the University of Pennsylvania Perelman School of Medicine, performed a qualitative analysis among female participants with moderate to severe acne at both the University of Pennsylvania and a private practice in Ohio.

Barbieri and colleagues enrolled a total of 50 women with a mean age of 48 years.

The team conducted free listing and open-ended, semistructured interviews over the phone.

“During the free-listing phase, participants were asked to describe the first words that came to their mind regarding acne treatments, treatment success, and adverse effects,” they explained. Results were then used to calculate Smith S for saliency.

The interviews were designed to elicit participants’ experiences with acne and treatment. “Because the Institute of Medicine has prioritized a need for comparative effectiveness research on long-term treatments for acne,” they added, “we additionally asked participants about their perspectives on participating in a theoretical comparative effectiveness trial to guide the design of a future trial.”

In the free listing, the most salient terms related to treatment success were clear skin (salience index, 0.67), no scarring (salience index, 0.09), and no acne (0.09). The most salient terms associated with treatment adverse effects were dryness (salience index, 0.67) followed by redness (salience index, 0.21) and burning (salience index, 0.14).

“When describing ways in which acne had affected their lives, participants consistently noted that their blemishes made them highly aware of their appearance,” the team reported.

Patients commonly expressed feelings of self-consciousness, depression, anxiety, and social isolation. Many participants shared that their acne particularly affected their mental health and well-being.

Even more, a common experience among patients was cancelling or postponing social interactions due to feelings of insecurity, especially during a flare-up. Self-esteem was largely impacted, which negatively affected experiences in romantic relations.

Patients also defined successful treatment as having completely clear skin over time or a manageable number of blemishes. While some were concerned with the physical symptoms of acne on their faces, others focused on resolving social and emotional consequences of their condition.

Many patients expressed frustration with finding a dermatologist with whom they could feel comfortable. There were also common frustrations in finding a provider who could identify effective treatments for their acne.

And finally, many patients were open-minded to the idea of participating in a comparative effectiveness clinical trial designed to understand and identify the best treatment regimens for acne. Some indicated they would partake in a study if they knew it would help with treatment and management of their and others' acne.

“The results of this qualitative study suggest that women with acne have strong concerns about appearance and experience mental and emotional health consequences and disruption of their personal and professional lives,” Barbieri and colleagues wrote. “In addition, many patients describe challenges finding effective treatments and accessing care”

As such, they supported the idea of comparative effectiveness clinical trials involving this particular patient population.

Patient Perspectives on the Lived Experience of Acne and Its Treatment Among Adult Women With Acne: A Qualitative Study

Studies are needed to determine the best treatment regimen for these patients.

Women with Acne Commonly Experience Depression and Social Isolation

Efforts to standardize opioid prescribing have shown Black patients are less likely than White patients to receive opioid medication for 

 treated in the emergency department (ED).

Despite the racial disparities in pain management, questions remain on the factors associated with the disparities, with some experts theorizing statistical discrimination where clinicians make choices based on generalizations about a group, rather than a patient.

Investigators, led by Zachary F. Meisel, MD, MPH, Perelman School of Medicine, University of Pennsylvania, observed the disparities in acute pain management in black patients compared to white patients remained after clinicians were given additional patient-level data, which suggested a lack of patient information is not associated with disparities in opioid prescribing.

The study addressed gaps in pain management through an examination of racial disparities in opioid prescribing through a secondary analysis of data from the Life Stories for Opioid Risk Reduction in the ED (Life STORRIED) randomized clinical trial.

Patients were enrolled between June 2017 - August 2019.

The team noted inclusion criteria compromise of presentation to the ED for uncomplicated ureteric colic or musculoskeletal back and/or neck pain, aged 18 - 70 years, and clinician intention to discharge patients ≥24 hours after enrollment.

Following randomization, patients were asked to complete a series of surveys including a demographic survey, pain management preference survey, and the Opioid Risk Tool (ORT) to assess risk of opioid misuse.

ORT has a score range of 0 - 26, with 0 -3 showing low risk, 4 - 7 moderate risk and ≥ 8 indicating high risk.

Investigators assessed the risk of opioid misuse using the ORT and collected self-report patient demographic data using a survey administered during the ED visit.

Main outcomes included a patient receipt of an opioid prescription at discharge from ED and concordance between patient preference for opioid-containing treatment and received treatment.

They defined concordant treatment if a participant who preferred opioids received a prescription at discharge or if a patient who did not prefer opioid did not receive a prescription at discharge.

A total of 1302 participants were enrolled in the Life STORRIED clinical trial, with a total of 1012 patients having complete data on demographic characteristics and treatment preferences in the secondary analysis.

Of the total, 671 patients (66.3%) were assigned to the treatment arm, while 341 patients (33.7%) were assigned to the control arm.

Demographics showed 563 patients (55.6%) self-identified as female, with a mean age of 40.8 years. Further, a total of 455 patients (45.0%) identified as White, while 384 patients (37.9%) identified as Black.

Data show 377 patients (37.3%) had preference for opioids at ED discharge, 238 patients (23.6%) received a prescription for opioids at ED discharge, and 659 patients (65.2%) received treatment concordant with preference.

Investigators observed white patients were more likely to receive a prescription for opioids at ED discharge compared with Black patients (33.7% versus 12.2%, P <.001).

In addition, after controlling for demographic and clinical features, black patients had lower odds compared to White patients of receiving prescription for opioid medication at ED discharge (OR 0.42; 95% CI, 0.27 - 0.65).

The team noted when considering patients who preferred and did not prefer opioids, Black patients still had lower odds of discharge with prescription for opioids compared with White patients.

Data show this among those who preferred opioids (OR, 0.43; 95% CI, 0.24 - 0.77) and among those who did not prefer opioids (OR, 0.45; 95% CI, 0.23 - 0.89).

“These disparities were not eliminated by assessing and providing clinicians with patients’ treatment preferences and risk of opioid misuse,” investigators wrote. “Future research is warranted to further examine alternative factors associated with prescribing disparities.

Patient Preference and Risk Assessment in Opioid Prescribing Disparities A Secondary Analysis of a Randomized Clinical Trial

Black patients received different opioid prescriptions compared to White patients, even after clinicians were given additional patient-level data. 

Racial Disparities in Acute Pain Management Not Linked to Treatment Preference  

The US Food and Drug Administration (FDA) has 

regarding the New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The FDA noted in the CRL that while the submitted data provided substantial evidence of efficacy in reducing serum phosphorus in CKD patients on dialysis, the extent of the treatment effect is of unclear clinical significance.

In addition, for the application to be approved, the company will need to conduct an additional trial to demonstrate clinically relevant treatment effects on serum phosphorus or on the clinical outcome assumed to be caused by hyperphosphatemia in the patient population.

No safety, clinical pharmacology, or non-clinical issues were identified within the CRL.

The company is expected to request a Type A meeting with the FDA to discuss the CRL and the potential to move forward in the approval process.

Mike Raab, president and chief executive of Ardelyx, noted the company’s disappointment stemming from the decision by the FDA in a statement.

"We continue to believe tenapanor represents an important, first-in-class treatment option for patients with elevated phosphorus,” Raab said. “We do not agree with the FDA's subjective assessment on the clinical relevance of the treatment effect of tenapanor in our studies which met all clinical endpoints agreed upon by the FDA.”

Further, Arnold Silva, MD, PhD, director of Clinical Research at Boise Kidney and Hypertension Institute, added his perspective on the negative consequences of poorly managed serum phosphorus and the need for new therapies.

“I've closely followed the extensive clinical development of tenapanor, not only as an interested nephrologist, but also as a clinical investigator,” Silva said. “I've seen the clinical benefits of tenapanor first-hand in my patients and I'm stunned that the FDA is not granting approval of this novel mechanism drug, despite extensive clinical data demonstrating its safety and efficacy." 

 to Ardelyx, Inc. identifying deficiencies in the NDA for tenapanor. They noted key issues included size and clinical relevance of the treatment effect.

The FDA noted the extent of the treatment effect of tenapanor is of unclear clinical significance, despite evidence of efficacy. 

FDA Issues Complete Response Letter to Ardelyx for Tenapanor in Treatment of CKD

The US Food and Drug Administration (FDA) approved the monoclonal antibody mepolizumab (Nucala) as a suitable treatment for patients with chronic rhinosinusitis with nasal polyps.

The biologic, which targets interleukin-5 (IL-5) proteins, will be used as add-on maintenance treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age or older who had inadequate responses to nasal corticosteroids.

Mepolizumab is the first anti-IL-5 biologic to be approved for adults with this condition.

Chronic rhinosinusitis with nasal polyps has affected more than 5 million people in the United States, which is roughly 2-4% of the national population. It is associated with development of polyps located within the nasal cavity, as well as inflammation in tissues associated with eosinophils.

Mepolizumab has achieved significant improvement regarding reducing nasal polyp size and nasal obstruction. Additionally, the data collected from the SYNAPSE study indicated a 57% reduction in the proportion of patients who had surgery in the mepolizumab group in comparison to the placebo group.

Mepolizumab had previously been approved for use in 3 other eosinophilic driven diseases, including 

eosinophilic granulomatosis with polyangiitis (EGPA)

In a statement from pharmaceutical company GlaxoSmithKline, Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP), expressed her excitement on the new FDA approval.

“We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery,” Winders said.

The biologic can now be used as an add-on maintenance treatment for patients who have struggled with former treatment and surgeries.

FDA Approves Mepolizumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

Research from the Rasul Akram Hospital of Iran found that the severity of 

chronic obstructive pulmonary disease (COPD)

 strongly influenced sleep quality in patients. Factors such as coughing at night, shortness of breath, reliance on medications, and sleep apnea have all been associated with COPD and have a significant effect on patients’ sleep quality, health status, and overall breathlessness.

The study was conducted primarily in Iran, where the prevalence of COPD is estimated to be 9-10%.

Considered by some health professionals to be the “forgotten dimension” of COPD, sleep disturbance has affected a myriad of patients. The disease is also expected to be the third leading cause of death globally in the coming decade.

Leading author Mirfarhad Ghalehbandi, MD and colleagues felt the severity of COPD and its effect on sleep quality in patients warranted research, which gave rise to the recent prospective, cross-sectional study.

They team investigated the potential links between forced exhalation volume (FEV1) and forced vital capacity (FVC) ratio with the quality of sleep and described the potential relationships between subjective sleep quality and the severity of COPD in individual patients.

From April 2019-March 2021, the investigators enrolled 158 patients into the study.

Participants were 18 years or older in age and had been diagnosed with COPD. They were also required to be current or ex-smokers with a history of more than 10 years.

The investigators excluded patients who required routine oxygen therapy, had underlying or concurrent disorders other than COPD, recent history of cerebrovascular accidents, obesity of any kind, or acute psychiatry disorder.

Each participant engaged with 2 questionnaires during the study: the Pittsburgh Sleep Quality Index (PSQI) and a Persian version of the COPD Assessment Test (CAT).

The PSQI was comprised of 7 different components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction that measures sleep complexity. Variables within the PSQI were scored on a scale of 0-3

The CAT questionnaire included 8 items intended to measure health-related quality of life (HRQoL). There were 4 stages that were developed based on the overall CAT scores: Stage 1 (mild), Stage 2 (moderate), Stage 3 (severe), and Stage 4 (very severe).

Finally, a modified Medical Research Council (mMRC) Dyspnea Scale was used to focus on the different physical activities that could cause dyspnea, and measured the severity of dyspnea in patients using a scale from 0-4 (4 being the most severe).

The investigators recorded the data presented in PSQI, FEV1, and CAT scores, as well as the FEV1/FVC ratio.

The FEV1/FVC scores were 62.6 ± 11.5 and 65.6 ± 14.9 %, while the CAT scores were 16.2 ± 7%. Scores for PSQI was 8.2 ± 3.8.

Ghalehbandi and colleagues noted that the association between PSQI score with FEV1 and FEV1/FVC ratio was not statistically significant (

 = 0.64 and 0.58, respectively), but the association between PSQI score with CAT score and dyspnea severity were statistically significant.

The study confirmed that patients with severe COPD sleep poorly, with a majorty of participants recording longer sleep latency, lower sleep efficiency, higher disturbance rates, and higher sleep medication intake.

Additionally, the CAT scores indicated that dyspnea, an independent factor, could also be linked to poor sleep quality and negative effects on the QoL during daytime for patients, results that were reported in previous studies as well.

“It is recommended for pulmonologists to ask COPD patients in routine clinical assessment about sleep quality, sleep disturbance, and daytime dysfunction,” the investigators concluded.

“The association between sleep quality, health status, and disability due to breathlessness in COPD patients,”

 was published online in The Clinical Respiratory Journal

Researchers note the severity of the disease significantly impacts patients’ sleep habits, medication intake, and general mental and physical health.

Poor Sleep Quality Recorded in COPD Patients

While previous studies have found differences in the gut microbiome may affect the development of 

, there is limited available data due to a small sample size.

Investigators, led by Trudy Voortman, PhD and Zhangling Chen, MD, PhD, Department of Epidemiology, Erasmus Medical Center, explored the association between gut microbiome composition with insulin resistance and T2D in 2 large population-based cohorts.

The team found the composition of gut microbiome may actually influence the development of T2D, while an increased gut microbial diversity can benefit insulin resistance and risk of T2D. 

The team performed an analysis from January 2018 - December 2020, with the primary outcomes including insulin resistance and T2D.

The cross-sectional study took place within 2 ongoing, population-based, prospective cohorts in the Netherlands, including the Rotterdam Study (RS) and the LifeLines-DEEP (LLD) for a total of 4671 participants.

The RS included a cohort study of participants ≥45 years (n = 3132) and the LLD was a population-based cohort of participants ≥18 years (n = 1539).

Investigators used the 16S ribosomal RNA method to measure microbiome composition in stool samples, collected between January 2012 - December 2013.

They identified α diversity using the Shannon index, richness, and Inverse Simpson index, β diversity through the Bray-Curtis dissimilarity matrix, and taxa to reflect gut microbiome composition.

They used the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and glucose and insulin were measured to calculate the assessment.

In addition, the team identified cases of T2D through fasting blood glucose concentration of ≥126 mg/dL, non-fasting blood glucose of 200 mg/dL, or the use of blood glucose-lowering drugs.

Data show a total of 193 T2D cases among the 2166 participants, with 1418 from the RS study and 748 from the LLD study.

Investigators observed a lower microbiome Shannon index and richness had an association with higher HOMA-IR (Shannon index -0.06; 95% CI, -0.10 to -0.02). They noted patients with T2D had lower richness than patients without diabetes (OR 0.93; 95% CI, 0.88 - 0.99).

In addition, the β diversity was associated with insulin resistance (R2= .004, 

Data show 12 groups of bacteria were linked to HOMA-IR or T2D.

A higher amount of christensenellaceae (β = −0.08; 95% CI, −0.12 to −0.03, 

 < .001), christensenellaceae R7 group (β = −0.07; 95% CI, −0.12 to −0.03, 

 < .001) and marvinbryantia (β = −0.07; 95% CI, −0.11 to −0.03, 

 < .001) was associated with lower HOMA-IR.

Moreover, an increased amount of clostridiaceae 1 (OR, 0.51; 95% CI, 0.41 - 0.65,            

 <.001), peptostreptococcaceae (OR, 0.56; 95% CI, 0.45 - 0.70, 

 < .001), C sensu stricto 1 (OR, 0.51; 95% CI, 0.40 - 0.65, 

 < .001), intestinibacter (OR, 0.60; 95% CI, 0.48-0.76; 

 < .001), or Romboutsia (OR, 0.55; 95% CI, 0.44-0.70; 

 < .001) was shown to have association with lower rates of T2D.

The team concluded a higher microbiome α diversity had an association with less T2D and lower insulin resistance in individuals without diabetes.

“An increased gut microbial diversity, along with specifically more butyrate-producing bacteria, may benefit insulin resistance and risk of type 2 diabetes,” investigators wrote. “These findings may help provide new insight into causes, mechanisms, and prevention of, as well as therapy for, type 2 diabetes.”

Association of Insulin Resistance and Type 2 Diabetes With Gut Microbial Diversity: A Microbiome-Wide Analysis From Population Studies

Higher microbiome α diversity had an association with less T2D and lower insulin resistance in individuals without diabetes. 

Gut Microbial Diversity Linked to Benefit in Insulin Resistance, Lower Risk of T2D

The US Food and Drug Administration (FDA) has approved a label expansion of onabotulinumtoxinA (Botox) to include 8 new muscles in the treatment of 

These additional muscles are brachialis, brachioradialis, pronator teres, and pronator quadratus in the elbow and forearm; lumbricals and interossei in the hand; and flexor pollicis brevis and opponens pollicis in the thumb.

The expanded label also includes the use of ultrasound as a muscle localization technique for these patients.

"Today's announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient's quality of life," said Mitchell Brin, MD, Senior Vice President and Chief Scientific Officer of BOTOX® & Neurotoxins at AbbVie, in a 

"This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients."

Adults may develop spasticity following stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Such individuals are likely to experience stiffness in the muscles of their upper and/or lower limbs and may lose voluntary control of them.

Signs of upper limb spasticity include a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist. These can lead to difficulty with posture and positioning and can largely impact the patient’s daily functioning and activities.

It is estimated that 6.7 million adults in the United States live with spasticity across a variety of neurologic conditions.

 for treatment of spasticity in patients 2 years of age and older.

OnabotulinumtoxinA treatment may now include 8 new muscles.

FDA Approves Botox Label Expansion for Upper Limb Spasticity

The US Food and Drug Administration (FDA) has approved the interchangeable biosimilar product insulin glargine-yfgn (Semglee) for the treatment of 

The agent is a long-acting human insulin analog with an indication to improve glycemic control in both adult and pediatric patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).

The approval for the first interchangeable biosimilar product in the United States to treat diabetes was granted to Mylan Pharmaceuticals, Inc.

As an interchangeable biosimilar product, the insulin-glargine-yfgn can be substituted for insulin glargine at the pharmacy-level without the intervention of the prescribing health care provider.

The standards for approval included the agent must be biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any patient.

Further, the risk in terms of safety or diminished efficacy of switching between the interchangeable product and the reference product can not be greater than the risk of the reference product without alternating between the 2 agents.

The agent met FDA approval for interchangeability based on evidence showing the products were highly similar, with no clinically meaningful difference between insulin glargine-yfgn and the insulin glargine in matters of safety, purity and potency.

In addition, the insulin glargine-yfgn is expected to produce the same clinical result as insulin glargine in any patient, with no risk in safety and efficacy from switching between the 2 agents compared to the use of the reference product.

The insulin glargine-yfgn is administered subcutaneously once daily. It is offered in 10 mL vials or 3 mL prefilled pens.

Its approval noted the dosing on insulin glargine-yfgn should be individualized based on patient need and should not be used during an episode of hypoglycemia, or patients with hypersensitivity to insulin glargine.

There were serious side effects observed, including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure.

The most common side effects of insulin glargine products included edema, lipodystrophy, weight gain, and allergic reactions including injection site reactions.

Janet Woodcock, MD, acting FDA commissioner, noted in a 

 that the interchangeable biosimilar product may greatly reduce healthcare costs in patients who rely on insulin daily for diabetes management.

“Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock said.

Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, agreed with the importance of access to affordable insulin and noted the FDA’s standards of approval for biosimilar products.

“The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product,” Stein said.

Data show no clinically meaningful difference between insulin glargine-yfgn and insulin glargine in matters of safety, purity and potency. 

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