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Oral relugolix NDA accepted for Priority Review by FDA

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Myovant Sciences’ New Drug Application for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by FDA.

“As recently published in the New England Journal of Medicine, relugolix demonstrated superior efficacy and a 54% lower risk of major adverse cardiovascular events compared to the current standard of care, leuprolide acetate injections, in the Phase 3 HERO study,” Lynn Seely, chief executive officer of Myovant Sciences, said in a statement.

FDA has set a target action date of December 20, 2020 under the Prescription Drug User Fee Act. In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application. If approved, relugolix would be the first and only oral gonadotropin-releasing hormone receptor antagonist treatment for men with advanced prostate cancer.

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