The European Medicines Agency (EMEA) says the authorization that was granted two years ago to Sanofi-Aventis to market its anti-obesity drug Acomplia (rimonabant) in the Eropean Union (EU) should be suspended because the drug’s advantages don’t outweigh the potential disadvantages which include a doubling of the risk of developing psychiatric disorders such as depression when compared with placebo.
The EMEA announced its recommendation on 23 October following the conclusion of its Committee for Medicinal Products for Human Use (CHMP). The CHMP reviewed new evidence from ongoing clinical trials and post-marketing experience of Acomplia and found that the benefits outweighed the risks which include psychiatric effects that the CHMP considers could not be “adequately addressed by further risk minimisation measures”.
Acomplia is approved in the EU for use with patients who are obese and patients who overweight and have other risks. The drug is prescribed as an adjunct to diet and exercise and has carried warnings about psychiatric side effects, and depression in particular, since it was first authorized in June 2006. The warnings have been strengthened twice since then to include further information about contraindications and management of risks.
The CHMP met on 20 – 23 October to consider all the available information on the benefits and risks of Acomplia, including data from studies that only finished after the drug had been approved. The committee concluded that the risk of patients taking Acomplia developing psychiatric disorders, and depression in particular, was double that of taking placebo.
The CHMP also said that the effectiveness of Acomplia is more limited than was expected from the pre-marketing clinical trials because in practice patients are only taking the drug for short periods.
The EMEA said doctors should stop prescribing Acomplia and review the treatment of any patients currently on the drug.
Patients taking Acomplia should talk to their doctor or pharmacist about their treatment. There is no immediate need to stop the drug, but patients who wish to do so can stop at any time said the EMEA. Patients taking part in an Acomplia clinical trial should talk to the investigator.
Acomplia (rimonabant) is a cannabinoid receptor antagonist that blocks the CB1 receptor that controls food intake. CB1 receptors are in the central nervous system and in fat cells.
The drug is currently approved for use with patients who are:
- Obese (BMI of 30 kg/m2 or more), or
- Overweight (BMI of 27 or more but less than 30 kg/m2) and have other risk factors such as diabetes type 2 or high levels of fat in their blood (dyslipidaemia).
Acomplia has been marketed in 18 EU Member States since it was approved in June 2006. The active agent rimonabant is also marketed outside the EU as Zimulti.
The proposed suspension now goes to the European Commission for a final decision and they are expected to go with the CHMP recommendation.
In a press statement, Sanofi-Aventis said they were fully complying with the EMEA’s recommendation to temporarily suspend Acomplia, and that they will be writing to doctors and other health professionals about the decision and they will also be discussing how to implement an equivalent decision outside the EU with the appropriate health authorities.
The drug company said it was confident that Acomplia will “remain a therapeutic answer to a highly prevalent and increasing unmet medical need”. In a press statement they highlight the point that trials are still ongoing and imply that while the current view is one of extreme caution, the full scientific process has not yet completed and the pendulum may well swing back again.
Sources: EMEA, Sanofi-Aventis.
Written by: Catharine Paddock, PhD.