Shire's NDA for gastrointestinal prokinetic agent accepted by FDA

6 March 2018

The Ireland-headquartered drugmaker Shire (LSE: SHP) was trading 2% higher on Tuesday after announcing that the US Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for prucalopride as a potential once-daily treatment option for chronic idiopathic constipation (CIC) in adults.

Prucalopride, a high affinity, selective serotonin type 4 (5 HT4) receptor agonist, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility.

"Today’s acceptance of the NDA reinforces the breadth and depth of Shire’s capabilities in gastrointestinal conditions"

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