Shire’s prucalopride has taken a giant leap towards approval after winning the support of an FDA advisory committee for chronic idiopathic constipation.
The Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of the drug supports its approval for this indication.
It also voted unanimously that the potential risk of cardiovascular adverse events with prucalopride treatment has been adequately addressed by the firm.
Prucalopride is a serotonin type 4 (5-HT4) receptor agonist designed to stimulate colonic peristalsis to increase bowel motility.
If the FDA follows the advice of its Committee, which it generally does, prucalopride will be the only readily available 5-HT4 receptor agonist in the US for adults with CIC, Shire noted.
“We are pleased with the advisory committee’s vote supporting prucalopride for the treatment of adults with chronic idiopathic constipation in the US, and will continue working with the FDA during the final stages of its review,” said Andreas Busch, head of Research and Development at Shire.
There are an estimated 35 million adults in the US with CIC, which is characterised by difficult, infrequent or incomplete passage of stools over a prolonged period and a range of symptoms.
The company says it expects a decision from the FDA by December 21 this year.
Prucalopride is already approved and available in the EU where it is marketed under the brand name Resolor, indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.