U.S. FDA Accepts New Drug Application for Prucalopride for Chronic Idiopathic Constipation

Shire (NASDAQ: SHPG) announces that the U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for prucalopride (also known as SHP555). Prucalopride is being evaluated as a potential once-daily treatment option for chronic idiopathic constipation (CIC) in adults.

As quoted in the press release:

“Today’s acceptance of the NDA reinforces the breadth and depth of Shire’s capabilities in gastrointestinal conditions and commitment to providing new treatment options for patients living with hard-to-treat conditions,” said Andreas Busch, Ph.D., Head of Research and Development at Shire. “If approved by the FDA, prucalopride will be the only readily available 5-HT4 agonist¹ in the United States for chronic idiopathic constipation in adults. We look forward to working with the FDA as the agency reviews our application.”

Click here to read the full press release.