Shire's Motegrity (prucalopride) Receives FDA Approval for Chronic Idiopathic Constipation (CIC) in Adults
Shots:
- The approval is based on six trials assessing Motegrity vs PBO in 2-484 patients with Chronic Idiopathic Constipation (CIC) in adults
- P-III study results: normalization of BM frequency (19-38% vs 10-20%); no increase in the risk of MACE events
- Motegrity (prucalopride) is a qd serotonin-4 receptor agonist (5-HT4) with its expected launch in 2019 in the US
Ref: GlobeNewWire | Image: WSJ
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