- Multaq® approved to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter -
- U.S commercial launch planned for the summer of 2009
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq® (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq® is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.
Multaq® is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%. The FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.
“The FDA approval of Multaq® is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of sanofi-aventis to provide patients and physicians with important new medicines in therapeutic areas with significant healthcare needs,” said Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. “Sanofi-aventis is proud of its ability to bring innovative therapies to market and contribute to reducing the public health burden of atrial fibrillation.”
The landmark ATHENA trial evaluated the efficacy and safety of Multaq® in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% were in NYHA class I-III with stable heart failure). This trial showed that Multaq® (dronedarone) 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.001) when compared to placebo, meeting the study’s primary endpoint.
This reduction was generally consistent across study subgroups based on baseline characteristics or medications. Patients taking Multaq® had higher rates of diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash than patients taking placebo.
Initiation of Multaq® treatment is contraindicated in patients with severe heart failure (NYHA class IV) or NYHA Class II – III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. This unstable population corresponds to the population of the ANDROMEDA trial in which patients receiving dronedarone had a greater than 2-fold increase in mortality compared to placebo.
The ATHENA and ANDROMEDA trials provided two sets of data supporting the assessment of the product’s benefit risk ratio in two significantly different patient populations.
To ensure the use of Multaq® in the appropriate patient population, sanofi-aventis U.S. LLC also announced the launch of mPACT™ – Multaq® Partnership for Appropriate Care and Treatment – the Risk Evaluation and Mitigation Strategy (REMS) developed by sanofi-aventis U.S. LLC. The mPACT™ Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of Multaq® while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.
“We are pleased that the FDA has granted approval of Multaq® for patients in a therapeutic area that has seen few new treatment options in the last twenty years,” said Marc Cluzel, MD, Senior Vice President, Research and Development, sanofi-aventis. “Sanofi-aventis’ commitment to research and development in this area is rewarded today, and we hope it will benefit many patients suffering from this disease.”
The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 2.5 million people in the United States and 4.5 million people in the European Union. Atrial fibrillation is a potentially life-threatening condition, with significant burdens on patients, health care providers and payers.
“It is exciting that Multaq® will now be available as a treatment option for patients with paroxysmal or persistent atrial fibrillation or atrial flutter,” said Professor Mohammed Zubaid, Kuwait University, Head of Cardiology Unit – Mubarak Alkabeer Hospital, cardiac Interventionist Consultant and Principal Investigator of Gulf Study for Atrial Fibrillation Events. “Based on clinical studies, Multaq® reduces the risk of cardiovascular hospitalizations in patients with atrial fibrillation / atrial flutter, this outcome could change the way we approach the management of the disease.”
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. Treatment with Multaq® can be initiated in an outpatient setting.
Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.
A registration dossier of Multaq® is also under regulatory review by the European Medicines Agency (EMEA).
