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Sanofi-aventis withdraws European application for marketing authorization for dronedarone (MULTAQ™) in the treatment of Atrial Fibrillation/Atrial Flutter

- New filing expected during the first semester of 2008 - Paris, France, September 7, 2006 - Sanofi-aventis announced today that it has taken the decision to withdraw the European application for Marketing Authorisation of dronedarone (MULTAQ™), 400 mg film-coated tablets intended for use in the treatment of Atrial Fibrillation / Atrial Flutter. In order to make a more adequate assessment of the benefit-risk balance of the product, the Committee for Medicinal Products for Human Use (CHMP) has requested additional clinical data which cannot be provided within the timeframe of the current procedure. Sanofi-aventis plans to resubmit a European application for Marketing Authorisation in atrial fibrillation/atrial flutter during the first semester of 2008, at the same period as planned in the United States. Dronedarone (MULTAQ™) is a new anti-arrhythmic drug (AARD), discovered and developed by sanofi-aventis in the management of atrial fibrillation and atrial flutter. Atrial fibrillation, which affects approximately 4.5 million Europeans, is a condition in which the upper chambers of the heart beat in an uncoordinated and disorganized fashion, resulting in a very irregular and fast heart rhythm. Atrial fibrillation, which is the most common type of irregular heart beat, can cause palpitations, shortness of breath and fatigue. The condition is increasingly frequent with advancing age and is often caused by age-related changes in the heart or as a result of cardiovascular disease. About sanofi-aventis Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

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Klara Kämpfer

Klara Kämpfer

Presskontakt Communications Business Partner (föräldraledig t.o.m. 08/2024)
Lovisa Fasth

Lovisa Fasth

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