Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

On May 9, 2022

Myovant Sciences and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA requires extended time to review additional information the Agency requested from the companies regarding bone mineral density. The extended Prescription Drug User Fee Act (PDUFA) goal date is August 6, 2022.

“We remain confident in the clinical profile of MYFEMBREE and its potential to become a therapeutic option for the management of endometriosis-associated pain,” said Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, Inc. “We will continue to work closely with the FDA to support the ongoing review of the sNDA.”

MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of up to 24 months.