ARTICLE | Clinical News
FDA panel votes in favor of Shire’s constipation product
October 19, 2018 7:37 PM UTC
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...
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