Sanofi Aventis: Plavix given new EU indication

Sanofi-Aventis and Bristol-Myers Squibb, the manufacturers of Plavix (clopidogrel), have announced that the European Commission has decided to approve a new indication for Plavix, the antiplatelet drug.

Patients with ST-segment elevation acute myocardial infarction (STEMI), a severe type of heart attack, who are also able to receive thromolytic drugs, may now also receive Plavix, which can help prevent the formation of blood clots.

The companies claim that the new approval is based on the findings of two clinical trials, where patients taking Plavix in combination with acetyl salicyclic acid (ASA) demonstrated a 36 per cent reduced chance of a second severe heart attack or death after eight days of taking the drug.

Keith A A Fox, professor of cardiology at the University of Edinburgh, remarked: “Plavix taken with ASA has previously been shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks.”

“Now, based on the results of two clinical trials … clopidogrel has been approved by the European Commission as showing benefit, together with ASA patients with the most severe types of heart attacks,” he added.

Recently, Plavix has been the subject of a legal battle between Apotex, an American generic drug manufacturer, and Sanofi-Aventis with Bristol-Myers Squibb.

Apotex had marketed a generic version of Plavix in the US and although a court ordered it to halt production, the company was not obliged to return any profits or recall sold products.

Sanofi-Aventis has had to revise its financial guidance for the year because of the unexpected impact of generic Plavix sales in the US. Both Sanofi-Aventis and Britol-Myers Squibb said they did not know exactly how much generic Plavix Apotex had sold, although they speculated that Apotex may have supplied enough to meet US market demand for the rest of 2006.

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