Myovant, Pfizer: FDA Accepts To Review Myfembree SNDA For Endometriosis -related Pain

Myovant Sciences (MYOV) and Pfizer Inc. (PFE) announced Thursday that the U.S. Food and Drug Administration accepted for review a supplemental New Drug Application or sNDA for MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).

The companies noted that the sNDA submission in endometriosis is supported by results from the Phase 3 SPIRIT program. It included two multinational, replicate pivotal clinical studies, i.e., SPIRIT 1 and SPIRIT 2, in over 1,200 women with pain associated with endometriosis for 24 weeks. It also included an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 through one year.

Endometriosis is an estrogen-dependent, inflammatory disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. This endometrial-like tissue outside the uterus results in chronic inflammation and can cause scarring and adhesions.

Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, said, "If approved for this indication, we believe MYFEMBREE has the potential to redefine care for women with endometriosis as an effective, one pill, once-a-day treatment option."

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 3 LIBERTY program.

Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

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