Update on Clopidogrel centralized applications in the European Union
Following its May 26-29th meeting, the CHMP issued a press release informing, amongst others, that positive opinions have been adopted for clopidogrel applications filed through the EMEA centralized procedure. Some of these applications concern formulations of clopidogrel with a different salt (besilate) when compared to Plavix® (clopidogrel hydrogen sulphate).
For applications filed through the Centralized Procedure (CP) at the EMEA, the scientific opinion issued by the CHMP is followed by a "Decision Making Process" at the European Commission level. This process takes usually 2.5 to 3 months. The end of the CP corresponds to the granting of a European Commission Decision valid throughout the EU. In countries where it is required, Pricing and
Reimbursement timelines need to be added.
Plavix® has an established efficacy and safety profile in the prevention of atherothrombotic events. It has been extensively studied in 9 large clinical trials involving more than 107,000 patients and prescribed to over 90 million patients worldwide.
With over a decade of real world experience, Plavix® continues to be studied in clinical trials to provide more evidence and protection for patients.
Sanofi-aventis will defend its legitimate intellectual property rights to the extent that they are applicable to any products containing clopidogrel.
Despite this CHMP scientific recommendation, sanofi-aventis confirms its EPS guidance for 2009.
About sanofi-aventis Sanofi-aventis is a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).