Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF). Despite receiving marketing authorizations in 41 countries, it has failed to gain the agency’s green light despite several submissions dating back over a decade, when the company was then known as Cardiome Pharma. 

The briefing documents charge the committee to consider the characterization of the safety profile of vernakalant for rapid conversion of recent onset AF and whether the data support a favorable benefit-risk profile of the drug. If the available data do not support a favorable benefit-risk profile, the FDA is asking whether the risk mitigation strategy (pre-infusion checklist) prospectively identifies patients at risk of poor CV outcomes following its administration. 

The company’s application is supported by data from SPECTRUM, a post-approval safety study that was conducted in Europe, which evaluated 1,778 unique patients across a total of 2,009 treatment episodes following administration of Brinavess. The data demonstrated that treatment with the drug successfully converted 70.2% of all treated AF patients into normal sinus rhythm (SR). In addition, treatment showed a median time to conversion of 11 minutes from the start of the first infusion among patients who successfully converted.  

Based on the data provided, the briefing docs report that “vernakalant has demonstrated serious safety liabilities (serious hypotension, ventricular arrhythmias, conduction abnormalities, death) in a target patient population (patients without heart failure, hypotension, valvular disease) in which poor cardiovascular outcomes with either pharmacologic cardioversion or electrical cardioversion are not expected.” 

As a result, the FDA concludes, “We do not believe that the benefit proffered by vernakalant, conversion of AFib to SR, outweighs the serious risks associated with its use.” 

Shares of Correvio (NASDAQ:CORV) gained 10 cents to close Monday at $1.40.

No Comments