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The US Food and Drug Administration (FDA) has now approved the heart drug Multaq (dronedarone) from French pharmaceutical firm Sanofi Aventis.
It is the first US-approved cardiovascular drug to reduce the amount of time patients with atrial fibrillation (AF) or atrial flutter (AFL) need to spend in hospital.
The new drug is an anti-arrhythmic designed to reduce the risk in patients with paroxysmal or persistent AF or AFL who exhibit associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.
Risk factors include being aged over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50mm or left ventricular ejection fraction (LVEF) up to 40%.
Says Sanofi Aventis CEO Christopher Viehbacher: “This is an important milestone … that demonstrates our commitment to providing patients and physicians with important new medicines.”
The FDA approval was based on five randomised clinical trials involving nearly 6,300 patients in multi-centres worldwide.
Copyright Press Association 2009