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FDA approves Myovant Sciences and Pfizer’s treatment for endometriosis pain

Published on 09/08/22 at 11:43am

The FDA has approved MYFEMBREE 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.

The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase SPIRIT 1 and SPIRIT 2 trials, published in The Lancet, and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE is also approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women, with a treatment duration of up to 24 months.

Myovant and Pfizer will continue to jointly commercialise MYFEMBREE in the US.

MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. Endometriosis is a severe, chronic condition caused by tissue similar to the lining of the womb growing in other places. MYFEMBREE inrroduces an option for up to two years of pharmacological management of moderate to severe pain associated with endometriosis in pre-menopausal women.  

“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms,” said Juan Camilo Arjona Ferreira, MD, CMO of Myovant Sciences, Inc. “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.”

“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said James Rusnak, MD, PhD, Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder.”

Lina Adams

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