Relugolix Granted FDA Priority Review as New Treatment Type

Relugolix Granted FDA Priority Review as New Treatment Type
The U.S. Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) Myovant Sciences submitted earlier this year requesting the approval of relugolix for the treatment of men with advanced prostate cancer. The priority review status will shorten relugolix's regulatory review for this indication from the standard 10 months to six months. The FDA has set a prescription drug user fee act (PDUFA) action date for Dec. 20. That means that the agency must decide by then whether to approve relugolix, which is given as a 120 mg tablet once per day. If approved, relugolix will become the first and only oral gonadotrophin-releasing hormone (GnRH) receptor inhibitor to win regulatory approval in the U.S. for the treatment of advanced prostate cancer. “We are delighted that the FDA has
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