Regeneron Pharmaceuticals has recently gained FDA approval for several indications, as detailed below12:
- Dupixent for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): The FDA has approved Dupixent for use in adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP. This expansion of the drug's label builds upon the initial FDA approval in CRSwNP for patients aged 18 years and older. The approval is based on data from two positive pivotal trials, SINUS-24 and SINUS-52, which demonstrated improvements in nasal congestion, polyp size, and sense of smell compared to placebo. Additionally, the safety profile of Dupixent in adolescents with moderate-to-severe asthma was also considered.
- Dupixent for Chronic Spontaneous Urticaria (CSU): Although the FDA previously rejected an application for Dupixent in CSU, the companies involved (Sanofi and Regeneron) are planning to resubmit their application with additional efficacy data. This indicates a potential for further FDA approval in the future.
These approvals and the planned resubmission underscore Regeneron's ongoing success in expanding the indications for its key drug, Dupixent, which is already a significant contributor to the company's revenue12.
9/21/2024 08:44am
