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Myovant : FDA Extends Review Of Myfembree In Pain Associated With Endometriosis To August 6

The U.S. Food and Drug Administration has extended the review period for the supplemental New Drug Application or sNDA for Myfembree for the management of moderate to severe pain associated with endometriosis. The extended Prescription Drug User Fee Act or PDUFA goal date is August 6, 2022, Myovant Sciences (MYOV) and Pfizer Inc. (PFE) said in a statement.

The FDA requires extended time to review additional information the Agency requested from the companies regarding bone mineral density.

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.

Endometriosis is a condition in which tissue similar to the uterine lining is found outside of the uterine cavity, which often causes disruptive symptoms like painful periods, fatigue, pain in the lower back and abdomen, heavy menstrual bleeding, and even painful or difficult sexual intercourse.

For endometriosis-associated pain, current treatment options include prescription and over-the-counter pain medications, oral contraceptives, GnRH agonists, and antagonists. There are also surgical options including adhesiolysis, cyst removal, and hysterectomy.

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