Regeneron & Sanofi’s Phase 3 Dupixent Data on Children Under Regulatory Review
By Judy Ya-Hsuan Lin
After receiving landmark approvals for adults and adolescents, Regeneron Pharmaceuticals, Inc. and Sanofi’s collaboratively developed atopic dermatitis (AD) drug, Dupixent (dupilumab) is expected to make a mark with its compelling efficacy and safety data in children aged 6 to 11 years. The critical results of the Phase 3 trial assessing the drug were presented at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5th. Both firms had been feeling optimistic toward an approval since last August when they revealed the topline positive results for the first time. Dupixent’s candidacy is currently being reviewed by regulatory authorities, including the U.S., Canada, and the E.U.
Since no biologic medicines are available for children with severe AD, the USFDA had given Breakthrough Therapy designation for Dupixent in 2016. Also, its Biologics License Application was under Priority Review with a target action date of May 26, 2020. The companies await Dupixent to be approved for children not receiving effective control with topical prescription medications and possibly even for children suffering from uncontrolled persistent asthma. However, the results of the drug on relieving asthma are expected only later this year. In summary, the performance of Dupixent along with the lately developed COVID-19 treatment has spiked Regeneron’s price return performance since late March 2020. Besides, Dupixent has been one of the dominant contributors to Sanofi’s sales since its launch.
The Phase 3 Clinical Trial Data
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, both of which induce type 2 inflammation correlated with AD, asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, and chronic rhinosinusitis with nasal polyposis.
The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy of Dupixent over the course of 16 weeks. Dupixent combined with standard-of-care topical corticosteroids (TCS) greatly suppressed disease symptoms and enhanced the quality of life in children. According to the data presented at the RAD Virtual Conference, almost three times as many children obtained clear to almost clear skin when administered with this combination.
In contrast to TCS alone, over 67% of children experienced at least a 75% overall improvement of their disease symptoms when treated with Dupixent combined with TCS. Additionally, the average EASI (Eczema Area and Severity Index) score, a measurement of the area and severity of atopic eczema, showed improvement from baseline in 82% and 78% of patients who received Dupixent every four or two weeks respectively as opposed to 49% for TCS alone. Furthermore, the severity of itch, the most commonly observed unpleasant symptom of AD, was reduced as early as two weeks after the first dose of Dupixent combined TCS, even continuing its efficacy throughout active treatment.
Safety, Effectiveness & Side Effects
The overall rates of adverse events were 65% for Dupixent every four weeks and 67% for every two weeks versus 73% for TCS alone. The most commonly observed adverse events with Dupixent were conjunctivitis, nasopharyngitis, and injection site reactions. Though the side effects were incurred in over half of the trial participants, Amy S. Paller, M.D., Professor of Pediatrics at Northwestern University Feinberg School of Medicine and principal investigator of the trial believe Dupixent will bring necessary relief for physicians and families struggling with severe AD. “Data from the Phase 3 trial in children aged 6 to 11 adds to the established efficacy and safety data in adults and adolescents and provides hope to physicians and families for a potential new treatment option for children with this chronic disease”.
Editor: Rajaneesh K. Gopinath, Ph.D.
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