Sanofi-aventis is Complying With the EMEA's Recommendation to Temporarily Suspend the Marketing Authorisation of Acomplia(R) in Obese and Overweight Patients
PARIS, October 23 /PRNewswire/ --
- Sanofi-aventis Will Comply With the European Authorities Request to Temporarily Suspend the Marketing Authorisation of Acomplia(R) in Obese and Overweight Patients and Will Make Every Effort to Actively Support Patients and Health Care Professionals in This Process.
- Sanofi-aventis is Committed to Provide Additional Evidence for the Re-evaluation of the Benefit / Risk Profile of Acomplia(R) in patients with diabetes and Cardiovascular Diseases Through the ongoing Clinical studies.
- Sanofi-aventis Remains Committed to Acomplia(R) to Bring an Important Therapeutic Approach to Obese and Overweight Patients.
Sanofi-aventis announced today that the European Medicines Agency (EMEA) has recommended to the European Commission (EC) the temporary suspension of the marketing authorisation of Acomplia(R) (rimonabant) for the approved indication of overweight and obese patients.
Acomplia(R) has been marketed in 18 EU countries since 2006 and has provided significant clinical benefits to patients suffering from obesity and overweight with associated co-morbidities.
Since the start of the commercialisation of Acomplia(R), sanofi-aventis has been closely collaborating with both the regulatory authorities and healthcare providers to monitor on an ongoing basis the real life use of the product and to ensure its use in the right patient population.
More than 700,000 patients have been treated with Acomplia(R) world-wide to date. In the postmarketing surveillance of Acomplia the safety profile of the product is aligned to the one described in the current European SmPC for the product and is consistent with the one observed during the clinical development.
"This first in its class medication continues to demonstrate great promise to reduce cardiometabolic risk and the pattern of side effects remains consistent across the randomized clinical trials conducted to date. As with any new drug category, more will be learned about optimizing benefit and minimizing risk through continuing controlled use of the medication in different patient populations. While the pendulum has swung in the direction of extreme caution with today's regulatory decision, at the end of the day, the medical community will allow the scientific process to unfold before rendering any final decisions about this medication's ultimate therapeutic potential" declared Robert Anthenelli, M.D. Professor of Psychiatry, Psychology and Neuroscience University of Cincinnati College of Medicine and Cincinnati Veterans Affairs Medical Center.
Sanofi-aventis believes that Acomplia(R) will remain an important therapeutic answer to a highly prevalent and increasing unmet medical need. As discussed with the EMEA, sanofi-aventis will continue the ongoing clinical trial program except phase IV and is committed to provide additional evidence for the positive re-evaluation of the benefit / risk profile of Acomplia(R), including through studies in diabetes and in patients at risk of cardiovascular disease.
Inline with its commitment to the EMEA, sanofi-aventis and its subsidiaries will inform Health Care Professionals as of today of the temporary marketing authorisation suspension. Patients who are currently taking Acomplia(R) should consult their doctor or pharmacist at a convenient time to discuss their treatment.
Sanofi-aventis will enter immediately in discussion with health care authorities in non European Union countries where Acomplia is available to determine how to implement an equivalent EMEA decision.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, 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). For more information, please visit: http://www.sanofi-aventis.com.
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