FDA Accepts Pfizer and Myovant Sciences’ sNDA of Myfembree

The FDA has accepted a supplemental New Drug Application (sNDA) for Pfizer and Myovant Sciences’ Myfembree (relugolix, estradiol and norethindrone acetate) for the treatment of premenopausal women with uterine fibroid-associated heavy menstrual bleeding.

The FDA approved Myfembree for the indication in 2021 with a treatment duration of up to 24 months. The companies now propose to update the prescribing information based on new efficacy and safety data from a late-stage study that supports a longer treatment.

“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,” said Juan Camilo Arjona Ferreira, Myovant’s chief medical officer.

The agency has set a Prescription Drug User Fee Act (PDUFA) decision date of Jan. 29, 2023 for the sNDA.