Posted by Michael Wonder on 07 Aug 2022
Myovant Sciences and Pfizer receive U.S. FDA approval of Myfembree, a once daily treatment for the management of moderate to severe pain associated with endometriosis
5 August 2022 - Data from the Phase 3 SPIRIT program showed Myfembree reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment.
Myovant Sciences and Pfizer today announced that the U.S. FDA has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once a day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.
