The U.S. Food and Drug Administration accepted a New Drug Application (NDA) to review SeysaraTM(sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older, Allergan plc and Paratek Pharmaceuticals, Inc. report.
SeysaraTM (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.
Allergan completed the NDA submission in October 2017, and expects the Prescription Drug User Fee Act (PDUFA) action date to occur in the second half of 2018. Allergan has U.S. rights to the development and commercialization of Seysara. Paratek retains all ex-U.S. rights.
"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," says David Nicholson, Chief Research and Development Officer at Allergan, in a news release. "This milestone reinforces our commitment to advancing research and bringing new therapies to patients, and our dermatology customers."
"The FDA's NDA acceptance is encouraging as results shown in the Seysara (sarecycline) Phase 3 trials involving 2,002 patients demonstrate that Seysara if approved, has the potential to be a new, effective, safe and well-tolerated treatment option for physicians treating patients with moderate to severe acne," adds Evan Loh, MD, President, Chief Operating Officer and Chief Medical Office at Paratek.
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. In March 2017, Allergan announced positive results of these Phase 3 studies, which met their primary efficacy endpoints.