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


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  • The FDA has approved Myovant Sciences Ltd (NYSE:MYOV) and Pfizer Inc's (NYSE: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.

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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


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