FDA advisory committee recommends Shire's Prucalopride for CIC
Shire announced that the FDA Gastrointestinal Drugs Advisory Committee voted unanimously 10 to 0 that the risk-benefit profile of prucalopride supports the approval of this New Drug Application. 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. The advisory committee 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 receptor agonist, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. Drugs similar to prucalopride have been associated with adverse cardiovascular events in the past. Prucalopride has been studied in more than 90 clinical trials worldwide over the last 20 years, including six key studies by which the advisory committee made its recommendation today. The advisory committee reviewed data included in the prucalopride NDA, specifically five main Phase 3 and one Phase 4 double-blind, placebo-controlled clinical trials. An integrated analysis of these six main randomized, controlled clinical trials evaluated the global efficacy and safety of prucalopride 2 mg daily in men and women with chronic constipation; study designs across the trials were similar. Overall, there were 2,484 adult patients included in the integrated efficacy analysis and 2,552 adult patients included in the integrated safety analysis; all patients included received prucalopride less than or equal to 2 mg daily or placebo. There are an estimated 35M adults in the U.S. with chronic idiopathic constipation.