Correvio Pharma drew a complete response letter from the FDA for its atrial fibrillation treatment Brinavess (vernakalant) because of inadequate safety data.
The agency said the data submitted with the NDA provided substantial evidence of the drug’s effectiveness but left questions about its safety. To support a resubmission of the NDA, the company will need to conduct another clinical trial to study the drug in patients at low-risk of adverse cardiovascular events.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted not to recommend approval of the NDA and called for further research. One committee member recommended that the agency lift the clinical hold on the NDA to allow for further study.
Correvio said that it will meet with the FDA “as soon as possible” to discuss the design of a potential study to address the agency’s concerns.