Unanimous FDA advisory panel vote backing prucalopride for CIC

e US Food and Drug Administration’s  Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of prucalopride (SHP555) supports the approval of this New Drug Application (NDA), said Ireland-headquartered Shire (LSE: SHP), which is in the late stage throes of an acquisition by Japan’s Takeda (TYO: 4502).

The FDA will take the advisory committee’s recommendation into consideration when the agency makes a final determination. The Prescription Drug User Fee Act (PDUFA) action date for prucalopride is December 21, 2018. If the FDA grants approval, prucalopride will be the only readily available 5-HT4 receptor agonist in the USA for chronic idiopathic constipation (CIC) in adults.

The advisory panel of experts also voted unanimously (10 to 0)that the potential risk of cardiovascular adverse events with the use of prucalopride in adults with CIC has been adequately addressed by Shire. Prucalopride, a serotonin type 4 (5-HT4) receptor agonist, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. Drugs similar to prucalopride have been associated with adverse cardiovascular (CV) events in the past.