Sceptical US FDA panel gives nod for Astellas overactive bladder drug
This article was originally published in Scrip
Executive Summary
With a somewhat tone of scepticism, a panel of advisers to the US FDA on 5 April backed approval of Astellas Pharma's experimental overactive bladder (OAB) drug mirabegron, voting 7-4, with one abstention, that the investigational medicine's benefits outweighed its risks of elevated heart rate, blood pressure and liver toxicity.