Real-World Evidence Fails Another Test At US FDA
Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.
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Low response rates in open-label, nonrandomized study raise questions about efficacy of the first-in-class EZH2 inhibitor relative to drugs currently used to treat the rare cancer, FDA says in advisory committee briefing document; retrospective natural history study also cannot be used to determine whether patients have better outcomes with tazemetostat than with available therapies.
Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.