The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Correvio Pharma regarding the New Drug Application (NDA) for Brinavess (vernakalant hydrochloride) for the conversion of atrial fibrillation.
Brinavess is an intravenously-administered antiarrhythmic drug that prolongs atrial refractoriness and slows impulse conduction in a rate-dependent fashion. The FDA noted in the CRL that while the data provided in the application substantiated the effectiveness of the drug, it did not provide reassurance of its safety. Earlier this month, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 2 to 11 against the approval of Brinavess.
According to the Committee, the SPECTRUM trial, which was meant to reassure the Agency of the safety of vernakalant, was found to have “significant limitations in the registry design (eg, non-consecutive enrollment) leading to selection bias.” Previous trials of vernakalant have reported serious cardiovascular adverse events including hypotension, bradycardia, ventricular arrhythmia, conduction disturbance, and death.
To address these concerns, the FDA is recommending that the Company conduct additional studies to assess the cardiovascular risk associated with Brinavess in patients who are at low risk of adverse cardiovascular reactions; the risk will need to be much less than 1% in this patient population, according to the CRL.
For more information visit correvio.com.
This article originally appeared on MPR