This is the third indication for the biologic therapy, following its approvals for adult AD and moderate to severe asthma maintenance care.
Dupilumab (Dupixent) has been granted its third indication by the US Food and Drug Administration (FDA).
The FDA has approved the Sanofi-Regeneron biologic for the treatment of moderate to severe atopic dermatitis (AD) in adolescents. It is now approved for treating both adult and adolescent AD, as well as for the maintenance treatment of moderate to severe asthma in patients aged 12 years or older.
With this indication—designated for patients aged 12 to 17 years old with AD not adequately controlled with topical prescription therapies or when such therapies are not advisable—dupilumab is now the first biologic therapy approved for the patient population.
The FDA approved dupilumab’s application based on evidence from a pivotal phase 3 trial showing the monotherapy was efficacious and safe in adolescents with uncontrolled moderate to severe AD in a trend consistent to that of previously tested adult patients. Investigators also noted that patients reported average Eczema Area and Severity Index (EASI) improvements of 66% from baseline—compared to just 24% in placebo-treated patients.
The trial also showed that nearly one-quarter (24%) of patients to receive dupilumab achieved clear or almost clear skin, as per Investigator’s Global Assessment (IGA) scoring, versus just 2% of patients on placebo. Another 42% of treated patients achieved EASI-75 (75% improvement) by trial’s end, and 37% achieved clinically meaningful improvements in itch—at least 4 points on the Peak Pruritus Numerical Rating Scale. Just 8% and 5% of patients on placebo achieved these marks, respectively.
Dupilumab was evaluated under Priority Review, indicating its potentially significant improvements in safety or efficacy for serious conditions, as well as under the Breakthrough Therapy designation.
Just last week, the FDA had accepted the supplemental Biologics License Application (sBLA) of dupilumab for the treatment of adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP), granting the application a PDUFA date of June 26.
In a statement, George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, noted the approval provides teenagers with a new therapy to help control the often debilitating AD symptoms of chronic itch and widespread rash. He teased the clinical potential of a specific-pathway targeting monoclonal antibody such as dupilumab.
"Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive phase 3 results and Priority Review of a US regulatory submission, and food and environmental allergies," Yancopoulos said.
In an interview with MD Magazine® while at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting in San Francisco, CA, Neil Graham, MD, MPH, vice president of Strategic Program Direction, Immunology & Inflammation for Regeneron, noted the company is also currently assessing the interleukin 4 and 13 (IL-4, IL-13) pathway inhibitor for various allergic and immunologic indications.
Current dupilumab investigations being undertaken by the company include indications for pediatric AD, pediatric asthma, eosinophilic esophagitis, and food and environmental allergies. Graham also expressed interest in the biologic being a potential treatment for chronic obstructive pulmonary disease (COPD).
“Now, this is I think no longer just a hypothesis—because we have an indication for atopic dermatitis driven by IL-4 and 13, for type 2 asthma driven by IL-4 13 and now CRS (chronic rhinosinusitis) with it nasal polyps,” Graham said. “We always felt that would be the real proof of the pudding, because you have essentially 3 different conditions in the same patient, all of which we think are type 2—and we now know are type 2 because dupilumab works for all of them.”