FDA Accepts Myovant Sciences and Pfizer's Filing For Review In Uterine Fibroids

Myovant Sciences MYOV and Pfizer PFE received U.S. Food and Drug Administration (FDA) acceptance of its supplemental New Drug Application (sNDA) review for its lead drug candidate MYFEMBREE for the treatment of patients with heavy menstrual bleeding associated with uterine fibroids.

The regulatory agency has assigned Standard Review for the application and set a PDUFA target action date of Jan. 29, 2023. 

The supplemental New Drug Application (sNDA) is supported by safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.

Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer, said, "Heavy menstrual bleeding is the most common symptom affecting women with uterine fibroids that can impact their daily life and activities over a long period of time. We are pleased to submit these study results to the FDA as they show the value MYFEMBREE can potentially have on treating women's uterine fibroid symptoms long term".

Myovant Sciences shares are trading 6% higher at $10.89 in the premarket session.