Myovant Sciences and Pfizer have announced the US Food and Drug Administration (FDA) has agreed to review a supplemental New Drug Application (sNDA) for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The agency reportedly has set a target action of May 6, 2022, under the Prescription Drug User Fee Act (PDUFA).
Juan Camilo Arjona Ferreira, Myovant’s chief medical officer, said the women suffering from endometriosis are in need of an effective treatment for their pain.
“Women with endometriosis often experience debilitating symptoms that impact their daily lives – and unfortunately, many of them do not find relief with the medical options that are currently available,” he said. “If approved for this indication, we believe Myfembree has the potential to redefine care for women with endometriosis as an effective, one pill, once-a-day treatment option.”
According to the two companies, the sNDA submission is supported by the results from their Phase III SPIRIT program. The trial included two multinational, replicate pivotal clinical studies (SPIRIT I and SPIRIT II) in a group of more than 1,200 women with pain associated with endometriosis for 24 weeks; it also included an open-label extension study for women who completed either SPIRIT I or II through one year.
James Rusnak (Pfizer’s senior vice president, chief development officer, internal medicine and hospital, global product development) said, “The submission of the sNDA for Myfembree to treat endometriosis pain reflects our commitment to addressing areas of significant unmet need in women’s health. We look forward to potentially bringing this important new treatment option to women with endometriosis.”
Myfembree currently is approved in the US for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The FDA approved the treatment for this specific indication on May 26, 2021, based on data from the Phase III LIBERTY program; Myovant and Pfizer are jointly developing and commercializing the treatment in the US.
Endometriosis is an estrogen-dependent, inflammatory disease that involves tissue like the uterine lining being found outside the uterine cavity (typically in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. Effects include pelvic and menstrual pain, pain during or after intercourse, fatigue, and infertility.
According to the World Health Organization, endometriosis impacts approximately one in 10 women (about 190m people) around the world. There currently is no known cure, but a number of treatments are available to help manage symptoms.