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

  Ref: Globe Newswire | Image: Myovant