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Home » FDA Expert Committee Votes in Favor of Shire’s NDA
FDA Expert Committee Votes in Favor of Shire’s NDA
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October 25, 2018
An FDA advisory panel voted unanimously to recommend Shire’s candidate treatment for adults with chronic constipation.
The Gastrointestinal Drugs Advisory Committee voted 10-0 that the drug’s risk-benefit profile supported approval of Shire’s new drug application for Motegrity (prucalopride).
In separate unanimous votes, the committee agreed that the company’s trial data showed the drug to be effective and that it adequately addressed the potential risk of cardiovascular adverse events.
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