FDA green light for Myovant and Pfizer's Myfembree

8 August 2022

Japanese drug major Sumitomo Pharma (TYO: 4506) has announced its consolidated subsidiary Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have received US Food and Drug Administration (FDA) approval for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) 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 as per the attachment.

The approval comes after the FDA extended its decision date in May this year, so that the agency could review additional information it had requested from the companies regarding bone mineral density.

Following the announcement on Friday, Myovant’s New York traded shares closed up 3.2% at $15.12.

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