FDA panel unanimously back's approval of Shire's prucalopride for chronic idiopathic constipation

An FDA advisory committee voted unanimously that the risk-benefit profile of Shire's prucalopride supports approval for the treatment of chronic idiopathic constipation (CIC) in adults, the company announced. The agency is set to make a decision on the marketing application by December 21.

Shire noted that the advisory panel also voted unanimously that the potential risk of cardiovascular adverse events with the use of prucalopride in adults with CIC has been adequately addressed. Drugs similar to prucalopride, which is a serotonin type 4 receptor agonist, have previously been associated with adverse cardiovascular (CV) events.

The advisory committee made its decision after reviewing data from six key studies, including five main Phase III trials. Results showed that in an integrated analysis of the studies, 27.8 percent of patients treated with prucalopride achieved an average of three or more spontaneous, complete bowel movements per week over the 12-week treatment period, versus 13.2 percent for placebo.

The panel also assessed results from a safety study, which measured the pooled adjusted incidence rate ratio (IRR), of major adverse CV events (MACE) in adult new users of prucalopride compared to adult new users of polyethylene glycol (PEG). Shire noted that the pooled adjusted IRR for MACE was 0.64 in this mostly female patient population, which excluded a threefold increase risk of MACE in patients using prucalopride compared with PEG.

Prucalopride is currently approved in Europe where it is marketed as Resolor for the symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. The product was first authorised in 2009 for use in women, gaining expanded clearance in 2015 to include men.

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