▎WuXiEdited by Kant Content Team

Today, Sanofi and Regeneron jointly announced that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for their重磅药物 Dupixent (dupilumab) and granted it priority review for use as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).The PDUFA date for this application is June 27, 2024.According to the press release, if approved, Dupixent will become the first approved biologic for the treatment of COPD and the first new treatment option for the disease in over a decade.China and the EU are also reviewing Sanofi and Regeneron's regulatory application for Dupixent to treat COPD.

The submission of this sBLA was primarily supported by positive data from the Phase 3 clinical development program for COPD, which evaluated the efficacy and safety of Dupixent in treating uncontrolled COPD adult patients who are currently or have previously smoked and have type 2 inflammation (blood eosinophils >300 cells/μL). All patients were receiving maximum standard-of-care inhaled therapy (almost all on triple therapy). The analysis showed that both trials (BOREAS, NOTUS) met their primary endpoints.Compared with placebo, Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% in patients.In both trials, compared with placebo, Dupixent also rapidly and significantly improved patients' lung function for up to 52 weeks.

The safety results of the two trials were generally consistent with the known safety profile of Dupixent in its previously approved indications. In both trials, the adverse events more common with Dupixent than placebo (≥5%) were back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Dupixent is a fully humanized monoclonal antibody that inhibits signaling in the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.Previously, dupilumab has been approved by the FDA for the treatment of diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE).

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References:

[1] Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation. Retrieved February 23, 2024 from https://www.sanofi.com/en/media-room/press-releases/2024/2024-02-23-06-00-00-2834219

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