Friday, August 18, 2006
Agency approves Plavix for heart attack care
FDA ratifies the use of the Sanofi-Aventis drug for STEMI patients.
WASHINGTON (Reuters) -- The Food and Drug Administration Thursday approved use of the Sanofi-Aventis drug Plavix to treat certain heart attacks.
The drug, first approved in the United States in 1997 as a blood thinner, can now also be marketed for patients who have experienced a type of heart attack known as acute ST-segment elevation myocardial infarction, or STEMI, but who will not have their arteries repaired.
Shares of Sanofi, a French drugmaker, were up in morning trade on the New York Stock Exchange. Shares of Bristol-Myers Squibb Co. (up $0.19 to $21.27, Charts), which sells Plavix in the United States for Sanofi, were up, also on the NYSE.
Once approved, a drug can by used for various treatments at a doctor's discretion. But the FDA's stamp of approval allows a company to legally advertise a drug for the approved uses.
Earlier this month, privately held Apotex, based in Canada, launched its cheaper generic version of Plavix in the United States. Plavix sales total $4 billion a year.
The FDA said it approved Plavix for patients who have had STEMI heart attacks after a trial of 46,000 patients in China showed the drug could help dissolve blood clots and reduce the risk of death when combined with other standard treatments.
The trial also showed the drug could reduce recurrent problems such as another heart attack or stroke, the agency said.
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