The FDA extended the review period for the supplemental new drug application (sNDA) for relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg (Myfembree; Myovant Sciences and Pfizer) for the management of moderate to severe pain associated with endometriosis. The agency requires extended time to review additional information it requested from the companies regarding bone mineral density. The extended Prescription Drug User Fee Act goal date is Aug. 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, MD, the chief medical officer of Myovant Sciences, in a press statement. “We will continue to work closely with the FDA to support the ongoing review of the sNDA.”

Myfembree was approved 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. Endometriosis often causes disruptive symptoms such as painful periods, fatigue, pain in the lower back and abdomen, heavy menstrual bleeding, and even painful or difficult sexual intercourse.

Based on a press release from Pfizer.