FDA panel votes in favor of Shire’s constipation product

FDA’s Gastrointestinal Drugs Advisory committee voted unanimously in favor of approving an NDA from Shire plc (LSE:SHP; NASDAQ:SHPG) for prucalopride to treat chronic idiopathic constipation (CIC). Its PDUFA date is Dec. 21.

The panel voted 10-0 that clinical trial data provide substantial evidence of effectiveness in CIC, that the potential risk of cardiovascular adverse events has been adequately addressed, and that the risk-benefit profile support approval of the NDA...