The FDA has approved Sanofi-aventis' Multaq (dronedarone) 400 mg tablets. Multaq is the first drug approved in the U.S. that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter, according to the firm.
Multaq is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent AF or atrial flutter, with a recent episode of AF/atrial flutter and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. The Paris-based Sanofi said that associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or left ventricular ejection fraction 40 percent.
The approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.
Despite high mortality rates associated with Multaq in the earlier ANDROMEDA trial, the more recent ATHENA trial evaluated the efficacy and safety of Multaq in patients with AF/atrial flutter or a recent history of these conditions (71 percent of these patients had no heart failure, 29 percent were in NYHA class I-III with stable heart failure). The results, presented at the 2009 meeting of the Heart Rhythm Society in May, found that Multaq had no adverse effect on mortality in AF patients with congestive heart failure and/or a left ventricular ejection fraction less than 0.35; and patients had a lower incidence of primary outcome events when allocated to dronedarone therapy.
To ensure the use of Multaq in the appropriate patient population, Sanofi-aventis said it is launching its mPACT - Multaq Partnership for Appropriate Care and Treatment - a risk evaluation and mitigation strategy. The program consists of a communication plan for healthcare professions, a medication guide for patients and post-marketing surveillance.
Multaq is to be given twice daily as a 400 mg tablet and should be taken as one tablet with the morning and evening meals, according to the company. Treatment with Multaq can be initiated in an outpatient setting. The most common adverse reactions to the drug are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.
Sanofi said that a registration dossier of Multaq is also under regulatory review by the European Medicines Agency (EMEA).