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FDA panel recommends antiarrhythmic drug for approval
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The Cardiovascular and Renal Drugs Advisory Committee recommended, with conditions, a new antiarrhythmia drug for market approval.
The panel voted 6-2 in favor of recommending FDA premarket application approval for the ion channel blocker vernakalant hydrochloride (Kynapid, Astellas Pharma Inc.). If approved, vernakalant would be the first pharmacologic therapy approved for the rapid conversion of atrial fibrillation in eight years.
“The safety information we have suggests that the upper limit of a confidence interval of the most feared complications is low and within acceptable limits,” A. Michael Lincoff, MD, interventional cardiologist and director of cardiovascular research at the Cleveland Clinic, said at the meeting. “People know that they have to be cautious with it, they have to monitor the patients, and that it may be an alternative to D/C cardioversion, a nontrivial procedure.”
He said the safety profile of vernakalant is comparable with ibutilide (Corvert, Pharmacia and Upjohn).
Limited by small sample
Pooled data from two pivotal randomized, placebo controlled pharmacological trials of the vernakalant clinical program provided much of the data the panel examined. The combined patient population of the two trials (n=601) contained 390 patients with AF and 231 who were exposed to vernakalant.
The data presented, even when drawn from the two pivotal studies and seven other studies that were part of the vernakalant clinical program, were limited. The panel recommended post-marketing studies and registries to collect more definitive data on a number of patient subgroups, such as women, blacks and those with heart failure. Ultimately, however, the panel decided that the data provided demonstrated reasonable safety and efficacy to merit recommendation.
One of the primary rationales for the panel’s recommendation of vernakalant was the documented ability of vernakalant to convert AF to normal sinus rhythm rapidly and to reduce the duration of physical discomfort patients with AF symptoms felt while being treated. - by Eric Raible
Large randomized trials in patients with minimally symptomatic AF have indicated there is no advantage to aggressively maintaining sinus rhythm vs. rate control alone. One issue in those studies is whether they are just saying we don’t have good drugs for maintaining normal rhythm. However, in patients presenting with highly symptomatic AF, there seems little doubt that conversion to normal rhythm relieves symptoms.
— Dan Roden, MD