5 March 2018 - Submission includes real-world evidence from an observational, pharmacoepidemiology cardiovascular safety study.

Shire announces that the U.S. FDA has accepted the submission of a new drug application for prucalopride (also known as SHP555). Prucalopride is being evaluated as a potential once-daily treatment option for chronic idiopathic constipation in adults. The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act action date with FDA noting that timelines are flexible and subject to change based on workload and identification of potential review issues.

An integrated analysis of the 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 ≤2 mg/day or placebo. Significantly more patients treated with prucalopride versus placebo (27.8% vs 13.2%; p<0.001) achieved an average of three or more spontaneous, complete bowel movements (SCBMs) per week over the 12-week treatment period.

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