The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess (vernakalant hydrochloride; Correvio Pharma) as a treatment for the rapid conversion of adult patients with recent onset atrial fibrillation.
The FDA is currently planning to hold an advisory committee meeting to discuss the application. The resubmitted NDA comes after the FDA issued a Refusal to File letter in August 2017, stating that the Company’s data package was not sufficient to support the resubmission.
The resubmitted NDA is supported by data from the SPECTRUM study conducted in Europe which evaluated 1778 patients across a total of 2009 treatment episodes following Brinavess administration. Results showed that Brinavess successfully converted 70.2% of patients into normal sinus rhythm (median time to conversion of 11 minutes). The Company also included data from nine phase 3 and phase 2 trials that were conducted over the last 8 years.
“The FDA’s acceptance of this resubmitted NDA marks another important milestone for Correvio and for the global Brinavess program,” said Mark H.N. Corrigan, MD, CEO of Correvio. “As a potential new AF treatment, with a well-characterized efficacy and safety profile, we believe that Brinavess, if approved, will be an attractive addition to the AF treatment landscape. We look forward to working with the FDA during the review process.”
Brinavess is an intravenously-administered antiarrhythmic drug that prolongs atrial refractoriness and slows impulse conduction in a rate-dependent fashion.
The Prescription Drug User Fee Act (PDUFA) action date for the NDA is December 24, 2019.
For more information visit correvio.com.