The FDA has accepted for Priority Review the supplemental marketing application for Dupixent (dupilumab) for children aged six months to 5 years with moderate-to-severe atopic dermatitis.
- Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc (NASDAQ:REGN) are developing Dupilumab.
- The application covers Dupixent as an add-on maintenance treatment for atopic dermatitis patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- The target action date for the FDA decision is June 9, 2022. Dupixent remains the only biologic medicine approved for patients six years of age and older in this indication.
- Related: CHMP Backs Sanofi-Regeneron's Dupixent For Asthma Patients Aged 6 - 11 Years With Type 2 Inflammation.
- The application is supported by data from the Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS).
- The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.
- Also See: Regeneron's Q4 Sales, Profits More Than Double With Boost From COVID-19 Treatment Sales.
- Price Action: REGN shares are up 0.06% at $620.12, while SNY stock is down 0.93% at $53.15 during the market session on the last check Thursday.
