Sanofi-Aventis is celebrating some good news about Acomplia after the UK’s healthcare funding watchdog, the National Institute for Health and Clinical Excellence, confirmed its recommendation for the use of the controversial obesity drug Acomplia on the National Health Service.
The UK decision is in sharp contrast to the announcement last year by the German Ministry of Health which stated that Acomplia (rimonabant) will not be reimbursed because it is a ‘lifestyle’ drug.
NICE, however, has recommended the drug as an addition to diet and exercise for obese or overweight adults who do not respond to or are intolerant of two other obesity drugs – Roche’s Xenical (orlistat) and Abbott Laboratories’ Reductil (sibutramine). The agency also recommends that rimonabant should be continued beyond six months only if the person has lost at least 5% of their initial body weight since starting the treatment.
NICE adds that Acomplia should be discontinued if a person returns to their pre-treatment weight and should not be taken for longer than two years without a formal clinical assessment and discussion “of the individual risks and benefits with the person receiving treatment”.
It is the risk/benefit ratio factor that has led to much of the controversy surrounding Acomplia. Earlier this month, the UK’s Medicines and Healthcare products Regulatory Agency posted data on its website which shows that there were 720 adverse event reports filed in the country between June 2006 and May 2008 related to the drug. Among five fatalities, there were two heart attacks, one case of infectious disease and one sudden death, as well as one case of suicide and two suicide attempts.
Acomplia was approved in Europe in 2006 but since then its progress has been hit with a number of setbacks. A marketing application was pulled in the USA after it looked unlikely that approval would be granted because of potential psychiatric side effects and in Europe there have been reimbursement issues, so the UK decision represents something of a win for Sanofi.
