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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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