Anaphylaxis

The FDA affirmed the planned NDA content and format for Anaphylm expected in Q1 2025, without requiring additional adult clinical trials before submission.

These data were explored to identify risk, recommendations, and guidelines related to vaccine-related allergic reactions such as anaphylaxis.

In recent findings presented at ACAAI 2024, patients, caregivers, and even emergency medical professionals were shown to face issues with regard to treatment of anaphylaxis reactions.

The Parental Self-efficacy in Managing Anaphylaxis (PSEMA) questionnaire was shown to be effective in assessing self-efficacy of parents in managing their childrens’ conditions.

Aquestive Therapeutics plans to submit an NDA for Anaphylm in Q1 2025 based on topline results from the Oral Allergy Syndrome challenge study.

Early epinephrine intervention at home can potentially successfully treat anaphylaxis in children without further treatment in a hospital setting.

During situations in which those with severe allergies suffer from fatal anaphylaxis, adrenaline autoinjectors were shown in this study to have little effect on such reactions.

In the allergy news space, this Month in Review highlights some of the most significant stories covered by the editorial team.

The announcement follows July’s approval of the nasal spray, also known as neffy, for patients with Type 1 allergic reactions such as anaphylaxis.

In this interview, Kim speaks about the significance of the FDA approval of neffy for patients who face the threat of anaphylaxis and other severe allergic reactions.

These new data were announced by Aquestive Therapeutics and if approved, Anaphylm Sublingual Film could be the first orally-delivered, non-invasive severe allergy treatment.

In an announcement by Aquestive Therapeutics, these new findings demonstrated the potential of this orally-administered epinephrine treatment.

These findings may allow for patients with severe allergic reactions to have an alternative to epinephrine auto-injector devices.

These results provided valuable insights into occupational anaphylaxis through the use of anaphylaxis registry data.

The seismic shifts in mentality for allergy management and the strides made in immunotherapy have kept parents of children with allergies hopeful, but changes are still needed.

These newly-updated parameters were a response by the ACAAI and the AAAAI to recent evidence that had become visible.

In this interview, Dr. Kim described his response to the FDA’s decision not to approve the intranasal epinephrine spray treatment for anaphylaxis and other severe allergic reactions.

The FDA's announcement requesting further study represents a step back in the process of 'neffy' becoming the first needle-free nasal spray epinephrine alternative.

This segment of Dr. Kim’s interview featured a discussion on the potential advantages and disadvantages of the new ARS-1 epinephrine nasal spray being considered by the FDA.

In a new interview with the HCPLive editorial team, Edwin H. Kim, MD, spoke about the new ARS-1 (Neffy) intranasal epinephrine spray for patients having Type 1 allergic reactions as well as the FDA's upcoming decision on the treatment.

This new research examined trends among adults with severe and recurrent anaphylaxis, and identified several major risk factors.

In phase 3 data presented at the AAAAI conference, an investigational intranasal epinephrine spray was found to have higher and more sustained pharmacokinetics than the standard reference product.

French researchers find that targeted allergy assessments may be needed in children with peanut allergies.

Dr. Mathias noted that investigators are continuing to determine if age plays a role in peanut allergy risk and sensitization.

Dr. Epstein provides updates on a joint study between members of AAAAI and the American College of Allergy on the relationship between epinephrine and post-immunotherapy injection waiting periods.