FDA accepts supplemental NDA for Myfembree.
The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).
The sNDA submission in endometriosis is supported by results from the Phase III SPIRIT program, which included two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) in over 1,200 women with pain associated with endometriosis for 24 weeks, and an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 through one year.
In the U.S., Myfembree is currently available for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The FDA approved Myfembree for this indication on May 26, 2021, based on data from the Phase III LIBERTY program. Myovant and Pfizer are jointly developing and commercializing Myfembree in the U.S.
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