A Food and Drug Administration advisory committee recommended the agency approve the intravenous version of
Vernakalant for abnormal heart rhythm.
Heart experts of the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6 to 2 to recommend approval of IV Vernakalant, the Canadian drugmaker's lead candidate. The drug, which will be branded in the U.S. as Kynapid, normalizes acute atrial fibrillation (AF), or irregular heart rhythm. The FDA isn't bound to follow the recommendations of an advisory panel, but it typically does.
Last week, Cardiome's shares gave up a couple of percentage points when an agency brief indicated some concern over incidents of heart spasms (one of which was fatal), in addition to a lack of data on the drug in patients with a history of heart problems.
Cardiome noted in a post-panel press release that, if approved, Kynapid will be the first new pharmacologic therapy for this indication in eight years. The PDUFA date, or the FDA's goal date to make a decision, for IV Vernakalant is Jan. 19.
Cardiome's co-developer for the IV formula, Japanese drugmaker
, has exclusive marketing rights in North America. Analysts are expecting modest peak sales and subsequent royalty revenue to Cardiome out of the IV form of Vernakalant but are more fixated on the oral version of the drug for chronic AF. Cardiome maintains exclusive rights to oral Vernakalant, and should present phase IIb data on it in March.
Shares closed at $9.26 on Tuesday.