The US Food and Drug Administration (FDA) has accepted for review Correvio’s resubmitted New Drug Application (NDA) for Brinavess (vernakalant hydrochloride, IV). The FDA initially cited insufficient data and refused to accept the initial submission in August 2017.
The antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients has been assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA), and in its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application.
The Brinavess NDA is supported by data from SPECTRUM, a post-authorisation safety study that was conducted in Europe and evaluated 1,778 unique patients across a total of 2,009 treatment episodes following administration of the drug.
The data demonstrated that treatment with Brinavess successfully converted 70.2% of those treated AF patients into normal sinus rhythm as well as treatment with Brinavess showing a median time to conversion of 11 minutes from the start of the first infusion among patients who successfully converted.
"The FDA's acceptance of this resubmitted NDA marks another important milestone for Correvio and for the global Brinavess program," said Mark Corrigan, CEO of Correvio. "As a potential new AF treatment, with a well-characterised 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.”
AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age. Early intervention with a rhythm-control strategy to prevent progression of AF may be particularly beneficial to patients.