TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ:SNY) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA's decision is expected by June 27, 2024.
This review follows positive results from two Phase 3 trials, BOREAS and NOTUS, which showed that Dupixent significantly reduced moderate or severe COPD exacerbations by 30% and 34% respectively, compared to a placebo. Both trials also demonstrated rapid and sustained improvements in lung function over 52 weeks with Dupixent versus placebo. The safety profile of Dupixent in these trials was consistent with its known safety profile in other approved indications.
COPD is a progressive respiratory disease characterized by breathlessness, coughing, and mucus production. Despite smoking cessation efforts, many individuals continue to suffer from COPD. Currently, approximately 300,000 people in the U.S. live with uncontrolled COPD with evidence of type 2 inflammation. If approved, Dupixent would be the first new treatment approach for COPD in over a decade.
Dupixent, developed using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. It is not an immunosuppressant. To date, the drug is approved for use in certain patients with conditions such as atopic dermatitis, asthma, and other diseases driven by type 2 inflammation in over 60 countries, treating approximately 800,000 patients globally.
Priority Review is granted to drugs that may offer significant improvements in the treatment, diagnosis, or prevention of serious conditions. The potential use of Dupixent for COPD is under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Regulatory submissions for Dupixent in COPD are also under review in China and Europe. This information is based on a press release statement.
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