Myovant Sciences Ltd. and Pfizer Inc. on Thursday said the U.S. Food and Drug Administration accepted their application for expanded approval of Myfembree for the management of moderate to severe pain associated with endometriosis.
The companies said the agency, which in May approved Myfembree for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, set a target action date of May 6 for the new indication.
Myovant and Pfizer, which are jointly developing and commercializing Myfembree in the U.S., said approval would provide a one-pill, once-daily treatment option for endometriosis, an inflammatory disease in which tissue similar to the uterine lining grows outside the uterine cavity.
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