FDA approves Myfembree for management of endometriosis pain

The FDA approved Myfembree for the management of moderate to severe pain associated with endometriosis, according to a press release from Myovant Sciences.

“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms,” Juan Camilo Arjona Ferreira, MD, chief medical officer of Myovant Sciences, said in the release. “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.”

The approval of the once-daily Myfembree pill (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg; Myovant and Pfizer) was supported by 1-year safety and efficacy results of the phase 3 SPIRIT 1 and 2 trials. These studies demonstrated significant reductions of dysmenorrhea and non-menstrual pelvic pain compared with placebo. Adverse events associated with Myfembree included vasomotor symptoms, abnormal uterine bleeding and fatigue.

In an open-label extension study, women who had taken Myfembree had a mean bone mineral density loss of less than 1% at the end of 1 year of treatment. However, 19.7% of patients had losses of more than 3%, according to the release.

“The data from the SPIRIT studies showed the clinical benefit that relugolix combination therapy can have on moderate to severe pain associated with endometriosis and how it can impact patients,” said Linda Giudice, MD, PhD, distinguished professor at the University of California, San Francisco, and chair of the SPIRIT Program Steering Committee, said in the release. “This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of less than 1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended.”

According to the release, Myfembree — which is jointly commercialized by Myovant Sciences and Pfizer — will be “available immediately to patients with moderate to severe pain associated with endometriosis with a prescription from their health care provider.”