USFDA accepts Pfizer, Myovant MYFEMBREE review application to treat endometriosis linked pain
Basel: Pfizer Inc. and Myovant Sciences have announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (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).
"Women with endometriosis often experience debilitating symptoms that impact their daily lives – and unfortunately, many of them do not find relief with the medical options that are currently available," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "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."
The sNDA submission in endometriosis is supported by results from the Phase 3 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.
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