The US Food and Drug Administration (FDA) has approval for and 鈥� Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with in pre-menopausal women.
Myfembree is a one-pill treatment indicated to be administered once daily for a treatment period of up to 24 months.
It is also intended for pre-menopausal women with heavy menstrual bleeding linked to uterine fibroids.
The companies will co-market the therapy in the region and will be made available soon.
The latest approval is based on one-year efficacy and safety findings, including 24-week data from the Phase III SPIRIT 1 and SPIRIT 2 clinical, as well as the first 28 weeks of an open-label extension study in those who completed either SPIRIT 1 or 2.
According to the data from these studies, Myfembree was found to reduce menstrual pain and non-menstrual pelvic pain with mean bone mineral density loss below 1% from baseline throughout the one-year treatment period.
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By GlobalDataAt week 24, both SPIRIT trials met the co-primary endpoints, with 75% of women receiving Myfembree having a clinically meaningful decline in dysmenorrhea versus 27% and 30% of women in the placebo arms, respectively.
Following Myfembree administration for non-menstrual pelvic pain, a clinically meaningful decline in pain was reported in 59% and 66% of subjects versus 40% and 43% of women in the placebo arms.
chief medical officer Juan Camilo Arjona Ferreira said: 鈥淓ndometriosis is a painful, chronic disease with limited therapies to manage symptoms.
鈥淭he new Myfembree indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis.鈥�
In May, the FDA extended the review period for supplemental New Drug Application (NDA) for Myfembree to manage endometriosis-associated moderate-to-severe pain.
