The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted eleven to two not to recommend approval of Correvio International’s NDA for vernakalant hydrochloride solution for treatment of recent onset atrial fibrillation.
Committee Chair Julia Lewis, who voted against approval, cited “the potential for fatal side effects” in high-risk patients including the elderly.
Paul Ridker, a professor of medicine at Harvard Medical School, who also voted against approval, called on the FDA to lift its clinical hold on the NDA to allow further study. “I don’t think this drug should be abandoned,” he said.
John Alexander, professor of medicine at the Duke University School of Medicine, who voted in favor of approval, said there is “a clear low-risk population” who would benefit from the drug. But he acknowledged that “more work is needed” to identify the cohort of low-risk patients.
The other “yes” vote came from Matthew Needleman, director of arrhythmia services at the Walter Reed Military Medical Center, who said the drug “has a role for a select group of patients.”