Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.
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Keeping Track: FDA Clears Motegrity And Second Herceptin Biosimilar, But Rebuffs SpecGx's Oxycodone
The latest drug development news and highlights from our US FDA Performance Tracker.
The New Zelnorm-al (Part 2): More Thoughts On The Revival Of The 5HT4 Class
Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.
Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets' Utility And Limitations
A European pharmacoepidemiology study helped reassure advisory committee members about the constipation drug’s cardiovascular safety, but confounding factors limited interpretability of the results and information about the study population’s racial makeup was lacking; nevertheless, panelists urged a similar study be conducted to assess potential carcinogenic and psychiatric risks.