Astellas of Japan and Canadian partner Cardiome Pharma Corp are celebrating after receiving the thumbs-up from the US regulator’s advisory panel for their heart drug Kynapid.

The Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) has recommended approval for Kynapid (intravenous vernakalant) for rapid conversion of acute atrial fibrillation. The panel members voted six to two in favour of approval and if it is forthcoming, the drug will be the first new pharmacologic therapy for the conversion of AF in eight years. The FDA is expected to make its final ruling on Kynapid by January 19.

AF, the most common cardiac arrhythmia, is an interruption of the normal sinus rhythm of the heart in which the two uppermost chambers of the organ beat irregularly and at an extremely rapid rate. About 2.2 million Americans suffer from AF in the USA and if it is left undiagnosed or untreated, life-threatening complications such as stroke can occur. Cardiome said that figure is expected to increase dramatically over the next 50 years due to an aging population, and the increased prevalence of risk factors including hypertension, obesity, diabetes and sleep apnea.

At least one patient in studies presented to support the filing died as a result of heart spasms that the FDA said were probably triggered by the drug. The panel also noted several incidents of dangerously low heart pressure among patients taking Kynapid but they have decided the benefit is greater than the risk.

In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialise Kynapid in North America, while the former has retained all rights to the intravenous formulations outside of Canada, the USA and Mexico. The Vancouver-based firm maintains exclusive rights to oral vernakalant, which analysts believe will be a more profitable treatment. Phase IIb data are scheduled to be presented on that formulation in March.