Sanofi (NASDAQ:SNY) and Regeneron (NASDAQ:REGN) Pharmaceuticals received Food and Drug Administration approval for their anti-inflammatory drug Dupixent to treat a rare skin disease, marking the eighth indication in the U.S. for this blockbuster medicine.
The FDA approved Dupixent on Friday as a treatment for adult patients with bullous pemphigoid, according to the companies.
This rare skin disease primarily affects elderly people and causes itching, blisters, lesions, and skin reddening.
The approval was based on results from a pivotal study that demonstrated more patients taking Dupixent achieved sustained disease remission and itch reduction compared to those on placebo.
The FDA evaluated the drug under priority review, a process reserved for medicines that may bring significant improvements to the treatment of serious conditions.
Bullous pemphigoid represents the eighth FDA-approved indication for Dupixent in the United States.
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