Sanofi-aventis suspends authorisation of Acomplia in obese patients
28 October 2008 00:00 in Pharmaceutical Company Product News
Sanofi-aventis has announced the European Medicines Agency (EMEA) has recommended the European Commission temporarily suspend the marketing authorisation of Acomplia (rimonabant) for the approved indication of obese and overweight people.
The company states Acomplia has been marketed in a total of 18 European Union (EU) countries since 2006 and has provided patients suffering from obesity - as well as overweight people - with "significant" clinical benefits.
In line with commitments to the EMEA, Sanofi-aventis notes it - and its subsidiaries - will inform healthcare professionals of the temporary marketing authorisation suspension.
People currently taking the drug should consult their pharmacist or doctor at a convenient time to discuss their treatment, the firm states.
It adds it will continue the ongoing clinical trial programme, except phase IV - and is committed to providing additional evidence for the positive re-evaluation of the benefit/risk profile of the therapy.
"Sanofi-aventis will enter immediately in discussion with health care authorities in non EU countries where Acomplia is available to determine how to implement an equivalent EMEA decision," the company concludes.
In recent days, the company and Medicines for Malaria Venture announced they have entered into a joint agreement to speed up the research and development of new malarial treatments.
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