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U.S. FDA Accepts New Drug Application for Prucalopride for Chronic Idiopathic Constipation
Mar. 05, 2018 09:05AM PST
Pharmaceutical Investing
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 …
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.”
