The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted not to recommend approval for the anti-arrhythmic drug Brinavess (vernakalant hydrochloride, IV; Correvio). The CRDAC met last week (10 December) to review Correvio’s New Drug Application (NDA) for Brinavess, and voted by a margin of 11–2 that the benefit-risk profile for Brinavess is not adequate to support approval.
Brinavess is Correvio’s anti-arrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients. Correvio’s NDA seeking approval for Brinavess is under review by the FDA with a target action date of 24 December 2019 under the Prescription Drug User-Fee Act (PDUFA).
The CRDAC, an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cardiovascular and renal diseases, makes appropriate recommendations to the FDA. The FDA is not required to follow the committee’s vote, although the agency considers the recommendations when making its decision. The final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
“We are disappointed with today’s outcome because we believe in the strength of the data we presented today for Brinavess,” Mark HN Corrigan, MD and chief executive officer of Correvio, said following last week’s CRDAC recommendation. “The treatment landscape is currently missing a rapid, efficacious and well tolerated option to treat patients with recent onset atrial fibrillation and we believe Brinavess has the potential to fill that unmet medical need. We remain confident in the safety and efficacy of the agent in the countries where it is approved and currently marketed.”
In a press release, Correvio said that the 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 Brinavess.
The SPECTRUM data, which was presented at the American Heart Association (AHA) 2019 Annual Meeting (16–18 November; Philadelphia, USA), demonstrated that treatment with Brinavess successfully converted 70.2% of those treated AF patients into normal sinus rhythm, Correvio said. Treatment with Brinavess showed a median time to conversion of 12 minutes from the start of the first infusion among patients who successfully converted, the company added.
FDA totally blindsided me on this one. Shows me… I should have done more research.