The Food and Drug Administration approved Dupixent as treatment for eosinophilic esophagitis in adults and children over the age of 12.
In its announcement Friday afternoon, the FDA approved a 300 mg dose of Dupixent to be administered weekly to treat patients with EoE. According to Regeneron and Sanofi, Dupixent is the “first and only medicine” specifically indicated to treat EoE in the U.S. The European Medicines Agency is currently reviewing Dupixent’s application and other foreign regulatory authorities are likely to receive regulatory filings for the drug by the end of the year.
EoE is a chronic disease of the esophagus, according to the Mayo Clinic, and can lead to difficulty swallowing or cause food to get stuck in the throat. In addition to treating EoE, Dupixent is approved for treating patients “atopic dermatitis, asthma or CRSwNP.”
“Eosinophilic esophagitis can be debilitating for patients by inflaming and damaging the esophagus and limiting the ability to eat normally,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent, in a statement. “Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and today’s approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation.”
“Our Phase 3 clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi, in a statement. “This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease.”
Dupixent has been a boon for the bottom lines of both Regeneron and Sanofi. In its latest quarterly report, Regeneron recorded total revenues of $2.9 billion, up 17% year-over-year. The company reported $1.81 billion in global net sales of Dupixent, up 43% year-over-year. Similarly, Sanofi’s sales rose 8.3% during Q1 2022.