The European Medicines Agency (EMEA) has been formally notified by Sanofi Pharma Bristol-Myers Squibb SNC of its decision to withdraw its application for a centralised marketing authorisation for the medicine DuoPlavin (fixed-dose combination tablets of 75 mg clopidogrel/75 mg acetylsalicylic acid and 75 mg clopidogrel/100 mg acetylsalicylic acid). DuoPlavin was expected to be used by patients already taking clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome.
The application for marketing authorisation for DuoPlavin was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agencyâs Committee for Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that the withdrawal of DuoPlavin was based on the request of the CHMP regarding the need to document bioequivalence based on the current guideline on bioavailability and bioequivalence. The company informed in the letter that it intends to perform a new bioequivalence study measuring plasma levels of clopidogrel parent compound to address the CHMP's request but the results of that study will not be available in the timelines defined by the centralised procedure.
More information about DuoPlavin and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website shortly.
For further information, please visit:
http://www.emea.europa.eu