Sanofi Aventis and Bristol Myers Squibb closer to approval for 300mg Plavix tablet

The European Committee for Medicinal Products (CHMP) has expressed a positive opinion about the 300mg loading dose Plavix tablet, Sanofi-Aventis and Bristol-Myers Squibb have announced.

According to the firms, the positive opinion means the drug is a step closer to final approval for use by patients with acute coronary syndrome (ACS), including those with unstable angina.

Four 75mg tablets of Plavix are bioequivalent to the 300mg tablet, which the firms said would “facilitate the use” of the approved loading dose of the former.

The firms said they remain committed to the further investigation of the optimisation of the loading dose of Plavix as part of the Current clinical trial.

Current – a randomised controlled international trial – studies ACS patients to consider the effect of different dosages of clopidogrel at various stages of the treatment process and results are expected at the end of this year.

Sanofi-Aventis and Bristol-Myers Squibb have indicated that the goal of the Current trial is to reduce a “composite endpoint” of stroke, myocardial infarct and cardiovascular death.

According to the Plavix website, the drug helps prevent blood clots, which cause in excess of 80 per cent of strokes and more than nine in ten heart attacks.