In a setback for Sanofi-Aventis, the Food and Drug Administration rejected the French drug maker's application to sell Multaq, a cardiovascular drug the company had hoped would become a blockbuster.
In a brief statement, Sanofi said the agency issued a "nonapprovable letter" for the drug's use against atrial fibrillation, a type of irregular heartbeat. Such a letter means the FDA found Sanofi's application didn't adequately demonstrate its safety or efficacy. Sanofi didn't say why Multaq was rejected but added it planned to resubmit the drug for approval in 2008, once it concludes a new clinical trial. A Sanofi spokesman declined to comment further on the FDA letter. An FDA spokeswoman also declined to comment.
Sanofi is the world's No. 3 drug maker by sales, behind Pfizer Inc. and GlaxoSmithKline PLC.
Multaq's rejection is a fresh blow for Paris-based Sanofi. Last month, a less costly generic copy began competing against one of its top-selling drugs, blood-thinner Plavix. Yesterday a U.S. district judge issued a preliminary injunction in favor of Sanofi and its U.S. marketing partner, Bristol-Myers Squibb Co., stopping Canadian drug maker Apotex Inc. from selling the generic version until he hears the partners' patent-infringement case. But he refused to order a recall of an estimated $500 million worth of generic Plavix that Apotex had already shipped.
Multaq, also known by the generic name dronedarone, is designed to treat heart arrhythmia, or an irregular heartbeat. Atrial fibrillation, which can cause blood clots and stroke, is one kind of arrhythmia, and 3% to 5% of people over 65 are afflicted with it, according to the American Heart Association.
Sanofi officials have predicted that Multaq could reach annual sales of more than $1 billion world-wide if it is approved for sale and expected much of it to come from the U.S. The company is still awaiting European regulators' verdict on Multaq.
In 2003 Sanofi halted one trial of the drug when it appeared that patients taking the drug were dying at a higher rate than those taking a placebo. Two other trials of Multaq showed that the drug has "absolutely fine" safety and efficacy, the Sanofi spokesman said.
Uncertainty hangs over two additional Sanofi drugs. The company is waiting for the FDA to approve obesity drug Acomplia. Earlier this year, the FDA postponed a decision on the drug, asking Sanofi for more information. European regulators have approved Acomplia, and Sanofi this summer began selling it in Europe.
Sanofi is also attempting to stop two generic companies from copying its blood-thinning drug Lovenox. Yesterday, the company said a patent-infringement case that it filed against the companies in a U.S. district court in California had been postponed until Dec. 4 from Oct. 10.
More new drugs to be approved at Drug Pipeline
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