Multaq dronedarone: Development discontinued

Sanofi discontinued development of Multaq to treat permanent AF after a significant increase in cardiovascular events in patients receiving twice-daily 400 mg Multaq compared to placebo was observed in the double-blind, international Phase IIIb PALLAS trial. The trial was subsequently discontinued based on recommendations from the study's operations committee and DMC. Sanofi said the patient population in PALLAS is different from the population for which Multaq is approved. The trial had enrolled 3,149 patients, of which 70% had permanent AF for >2 years and about 70% had New York Heart Association (NYHA) class I-III heart failure at baseline. Multaq is approved in the EU to prevent recurrence of AF or to lower ventricular rate in patients with non-permanent AF. In the U.S., the drug is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent AF or atrial flutter. ...