Rimonabant Suspended in EuropeFriday, October 24, 2008
The big obesity news yesterday was the recommendation of the European Medicines Agency (EMEA) to suspend the marketing authorisation of the CB-1 antagonist Acomplia® (rimonabant) across the European Union (EU).
According to the press release, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia for the treatment of overweight and obese patients no longer outweigh its risks.
Acomplia has been authorised in the EU since June 2006 as an adjunct to diet and exercise for the treatment of obese patients or overweight patients with associated risk factors, but has not been launched in the US or Canada.
Warnings about psychiatric side effects, in particular depression, have been included in the product information since Acomplia was first authorised and has been continuously updated and strengthened to include further contraindications and upgraded warnings on these concerns to manage the risks associated with the use of this drug.
Based on a recent reassessment of the data, the CHMP concluded that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking placebo.
The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side effects could not be adequately addressed by further risk minimisation measures.
In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period.
Prescribers were informed that they should not issue any prescriptions for Acomplia and should review the treatment of patients currently taking the medicine. Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment. There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.
EMEA recommends that patients currently included in clinical trials with Acomplia contact the investigator, who will be able to provide more information.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU countries.
More information on Acomplia is available in the European Public Assessment Report (EPAR) on the Agency’s website.
In a statement released by Sanofi-Aventis, the maker of Acomplia states that it will comply with the European Authorities request to temporarily suspend the marketing authorisation of Acomplia® in obese and overweight patients and will make every effort to actively support patients and Health Care Professionals in this process.
Clearly, the decision, which comes after the recent announcement from Merck, who decided to discontinue its Phase III program for taranabant, does not bode well for this class of anti-obesity drugs.