Astellas Wins FDA Panel Backing for Overactive Bladder Drug
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Astellas Pharma Inc.’s mirabegron treatment for overactive bladders won the backing of advisers to U.S. regulators despite the drug being linked to high blood pressure and other side effects. The stock rose.
A Food and Drug Administration advisory panel voted 7-4 to recommend approving the drug yesterday, saying mirabegron is beneficial and adequately safe. The agency isn’t required to follow the panel’s recommendations and is scheduled to decide by June 29.