The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences’ Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis 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.
At 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.
Myovant Sciences chief medical officer Juan Camilo Arjona Ferreira said: “Endometriosis is a painful, chronic disease with limited therapies to manage symptoms.
“The 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.”
In May, the FDA extended the review period for supplemental New Drug Application (NDA) for Myfembree to manage endometriosis-associated moderate-to-severe pain.