Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids

May 27, 2021 Auto Bot approval, FDA, Pfizer, regulatory, Uterine Fibroids 0

Shots:

  • The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 mg & norethindrone acetate 0.5 mg) vs PBO for heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration for up to 2yrs.
  • The P-III studies met their 1EPs i.e response to the treatment (72.1% & 71.2% vs 16.8% & 14.7%) @24 wks., MBL volume reductions (82.0% & 84.3%) from baseline respectively
  • The companies will jointly commercialize the therapy in the US with its expected availability in June’2021

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Myovant

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