Type of information: Granting of a Market Authorisation in the US
Product name: Seysara™
Therapeutic area: Dermatological diseases
- antibiotic. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
Company: Allergan (Ireland) Paratek Pharmaceuticals (USA - MA)
Disease: moderate to severe acne
- • On October 2, 2018, Paratek Pharmaceuticals announced that the FDA has approved Seysara™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights of Seysara™for the treatment of acne to Allergan , who has assigned such rights to Almirall. Paratek retains development and commercialization rights in the rest of the world.
- Paratek earned a $12 million milestone payment upon FDA approval and is now entitled to receive tiered royalties at rates ranging from high-single to low double digits on net sales of Seysara™.
- • On December 20, 2017, Allergan and Paratek Pharmaceuticals, announced that the FDA has accepted a New Drug Application (NDA) to review Seysara™ (sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. 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.
- 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
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2018-10-02
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: