The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Allergan to review Seysara (sarecycline) for the treatment of moderate to severe acne vulgaris in patients nine years of age and older. Seysara is a once daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
The application includes two identically designed, large, multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies, which demonstrated that once-daily sarecycline 1.5 mg/kg significantly improved acne severity based on Investigator's Global Assessment (IGA) success and significantly reduced inflammatory lesion count vs. placebo at week 12 in patients with moderate to severe facial acne vulgaris.
“We are pleased that the FDA has accepted our application and look forward to advancing our conversations toward a potential U.S. approval of Seysara in the second half of 2018,” said David Nicholson, chief research and development officer at Allergan. “This milestone reinforces our commitment to advancing research and bringing new therapies to patients, and our dermatology customers.”