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Sanofi-Aventis, SNY
After Hours: 29.65 -0.69 (-2.27%) 2:32pm ET
NEW YORK (AP) -- Sanofi-Aventis SA said Thursday its drug Multaq, which treats irregular heart rhythms, received marketing approval after a delay of nearly three years.
Multaq is intended to treat atrial flutter and atrial fibrillation, a disease in which the upper chambers of the heart do not beat regularly, which can cause strokes and death. Sanofi-Aventis said Multaq is the first drug for atrial fibrillation that has been shown to reduce hospitalization due to cardiovascular problems.
Atrial flutter can develop into atrial fibrillation.
Multaq, or dronedarone, will be sold in 400-milligram tablets intended to be taken twice per day. Sanofi-Aventis plans to launch the drug this summer. The company estimates there are 2.5 million atrial fibrillation patients in the U.S., and another 4.5 million in the European Union, where it is also seeking marketing approval.
In August 2006, the Food and Drug Administration told the French drugmaker that its marketing application did not contain enough data for approval. Since then, Sanofi-Aventis completed two major studies of Multaq. One showed it helped reduce hospitalization and death from heart-related problems by 24 percent, and the other showed it lowered the risk of both ischemic and hemorrhagic stroke by 34 percent. Both were significantly better than a placebo.
About
Sanofi-Aventis, a pharmaceutical company, contributes to enhancing life by providing an offering of medicines, vaccines, and integrated healthcare solutions adapted to local needs and means primarily in Europe and the United States. The company has products in the areas of thrombosis, cardiovascular, metabolic diseases, oncology, central nervous system, internal medicine, and vaccines. Its primary medicines include Lovenox/Clexane, Plavix/Iscover, Aprovel/Avapro/Karvea, Tritace/Triatec/Delix/Altace, Lantus, Amaryl/Amarel/Solosa, Acomplia, Taxotere, Eloxatine, Stilnox/Ambien/Myslee, Copaxone, Depakine, Allegra/Telfast, Nasacort, Xatral/Uroxatral, and Actonel/Optinate/Acrel. The companys vaccines principally include pediatric combination and poliomyelitis vaccines, influenza vaccines, meningitis/pneumonia vaccines, adult and adolescent booster vaccines, and travel and endemic vaccines. It has collaboration agreements principally with Novozymes, Dyax Corp., Oxford BioMedica, Regeneron, IDM, Zealand Pharma, UCB, and Crucell N.V., as well as partners, including Immunogen, Coley, Wayne State University, Innogenetics, and Inserm.
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