Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) said early Friday that the US Food and Drug Administration approved Dupixent for the treatment of adult patients with bullous pemphigoid.
Bullous pemphigoid is a potentially chronic and relapsing skin condition that can cause intense itching, blisters and lesions, as well as reddening of the skin.
The FDA approval is based on results from a phase 2/3 trial on Dupixent, which demonstrated improvements in sustained disease remission, clinically meaningful itch reduction and oral corticosteroid use, compared with placebo in adults with bullous pemphigoid, according to the companies.
The approval represents the eighth disease that Dupixent is now cleared to treat in the US, the firms said.
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