FDA's Cardiovascular and Renal Drugs Advisory Committee voted to approve Astellas Pharma/Cardiome's new drug application for its antiarrhythmic Kynapid (vernakalant hydrochloride injection) Dec. 11.

The committee voted 6-2 in favor of approving vernakalant, a potassium and sodium channel blocker, for use in conversion of atrial fibrillation to sinus rhythm.

"We are very pleased with the outcome of the meeting today and the vote in favor of approval," Astellas senior VP-research and development Bill Fitzsimmons told "The Pink Sheet" DAILY.

Concerns included the safety profile and relatively small data set from the sponsors' four clinical trials, including the lack of hypotension data and the uncertainty of risk of torsade de pointes.

"We certainly see that the safety of vernakalant is very good and well characterized," Fitzsimmons told "The Pink Sheet" DAILY. "We're very pleased with the quite low rate of torsades. It's a clear differentiator from other pharmacological therapies."

In particular, the committee's recommendation could push vernakalant ahead of Pfizer subsidiary Pharmacia and Upjohn's Corvert (ibutilide), a currently approved antiarrhythmic treatment for conversion of atrial fibrillation. Ibutilide has a black box warning on the risk of potentially fatal arrhythmias in association with torsade de pointes.

The committee also recommended that the indication remain narrow to prevent adverse events due to contraindications with symptomatic and/or decompensated congestive heart failure, acute myocardial infarction or acute coronary syndrome.

A strong post-marketing surveillance program should include more safety data, particularly among a wide range of demographics, the committee suggested. Astellas said that an observational study assessing adverse events including bradycardia, hypotension and torsade de pointes is planned. The user fee action date is set for January 19, 2008.

The Cardio-Renal committee is meeting for a two-day session on antiarrhythmia NDAs. The second drug under consideration, Solvay Pharmaceuticals' Pulzium (tedisamil sesquifumarate intravenous solution) will be reviewed Dec. 12 (¹ Also see "Dosing Schedule For Solvay’s Pulzium Will Be Addressed During Cardio-Renal Meeting" - Pink Sheet, 10 December, 2007.).

- Becky Jungbauer (b.jungbauer@elsevier.com)

Astellas/Cardiome’s Vernakalant Wins Advisory Committee Approval In 6-2 Vote

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