March 2, 2018
FDA accepts Regeneron’s marketing application Dupixent for asthma
© Reuters. FDA accepts Regeneron’s marketing application Dupixent for asthma
- Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi (NYSE:SNY) announce that the FDA has accepted for review Regeneron’s marketing application seeking approval for DUPIXENT (dupilumab) as add-on maintenance treatment in certain adults and adolescents at least 12 years old with moderate-to-severe asthma. The agency’s action date is October 20.
- DUPIXENT is currently approved the U.S. for atopic dermatitis.
- Dupilumab, a fully human monoclonal antibody, works by binding to (inhibiting) interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play key roles in Type 2 inflammation in moderate-to-severe asthma.
- Previously: Sanofi and Regeneron’s Dupixent OK’d in Europe for atopic dermatitis (Sept. 28, 2017)
- Now read: Some Thoughts On The Continued Negative Media For Regeneron