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After AdComm rejection, Correvio Pharma hit with FDA complete response letter

December 27, 2019 / Ben Adams

Correvio Pharma is not having a happy holiday. After being hit by an FDA AdComm rejection a few weeks back, its heart drug has now also been denied approval by the FDA.   In the AdComm, the Canadian company saw an overwhelmingly negative vote (11-2) against its drug to correct irregular rhythm in the upper chambers of the heart in adult patients. It was voted down over serious safety risks including low blood pressure and irregular rhythm in the lower heart chambers along with deaths during the trials. The drug, known as Brinavess (vernakalant IV), is approved outside the U.S. but needs U.S. sales to boost its share, which could swell to $150 million from the American market. The drug has a long record, as it tried and failed to gain FDA approval over the past 13 years and has also seen the regulator put the drug on a clinical hold.