Astellas ‘believes in therapeutic value of Kynapid’

Astellas Pharma has reiterated its believe in the therapeutic value of Kynapid (vernakalant hydrochloride) injection as a treatment of atrial fibrillation.

Atrial fibrillation occurs when electrical signals in the heart malfunction and is a potentially life-threatening condition.

The US Food and Drug Administration has sent an approval letter to Astellas and its co-development partner Cardiome Pharma.

It informed Astellas its review of the new drug application for the compound is complete and the application is approvable, while the regulator requires further information relating to the risk of previously identified events experienced by some patients before considering approval.

Kynapid is currently under review for the rapid conversion of atrial fibrillation to sinus rhythm.

Astellas was granted an exclusive licence to develop and commercialise the compound in North America from Caridome in October 2003.

William E Fitzsimmons, senior vice-president of research and development at Astellas, said: “Astellas and Cardiome strongly believe in the therapeutic value of Kynapid based on clinical trial data and are confident it will be an important therapy in the treatment of atrial fibrillation.

In June 2006, a study published in the Journal of the American College of Cardiology established the effectiveness of an electric procedure designed to prevent atrial fibrillation but warned it was too expensive for widespread use.