FDA Approves Myovant Sciences/Pfizer's Treatment For Endometriosis-Associated Pain

The FDA has approved Myovant Sciences Ltd MYOV and Pfizer Inc's PFE once-a-daily Myfembree for moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.
The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials and the first 28 weeks of an open-label extension study.
Overall, these studies showed that Myfembree reduced menstrual pain and non-menstrual pelvic pain with a loss of mean bone mineral density of less than 1% from baseline through one year of treatment.
Also Read: Myovant, Accord Healthcare Ink Relugolix Distribution Pact For Europe In Prostate Cancer.
Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is also approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.
Myovant and Pfizer will continue commercializing Myfembree in the U.S., and the product is available immediately.
Price Action: PFE shares are down 0.37% at $49.09 during the premarket session on the last check Monday. MYOV shares closed at $15.12 on Friday.