ObsEva SA: ObsEva Provides Business Outlook for 2021
GENEVA, Switzerland and BOSTON, MA (February 10, 2021) - ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women s reproductive health, today provided a corporate update, including its roadmap for advancing its clinical programs in 2021. We made significant progress across all aspects of the company in 2020, most significantly preparing Yselty for uterine fibroids for regulatory approval with a filed and validated European marketing authorization application and an upcoming planned new drug application in the US, said Brian O Callaghan, CEO of ObsEva. Meanwhile our other pipeline programs have continued to advance through development as evidenced by the recent exciting topline results from the PROLONG Phase 2a proof-of concept study of ebopiprant which, to our knowledge, is the only candidate drug in active development that has the potential to delay deli
for Uterine Fibroids
ObsEva is developing Yselty®, an oral GnRH receptor antagonist with the potential to treat more women thanks to its potential best-in-class efficacy, a favorable tolerability profile and unique, flexible dosing options for the treatment of uterine fibroids. Following the European Medicine Agency’s (EMA) recent validation of the marketing authorization application (MAA), a major milestone toward making Yselty® available in the E.U., the Company will continue to work closely with the EMA to achieve marketing approval, projected in Q4:2021.
The second key objective for 2021 will be to submit a U.S. New Drug Application (NDA), projected in Q2:2021, that will include the Week 76 post-treatment follow-up results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 mg, with a