NICE recommends Sanofi's obesity drug Acomplia

The UK's National Institute of Health and Clinical Excellence (NICE), the body responsible for advising the government on drug coverage in England, Wales and Northern Ireland, has recommended Sanofi-Aventis' controversial drug Acomplia (rimonabant) as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of or are contraindicated to other anti-obesity agents.

Last year (Marketletter July 9, 2007), the firm decided to withdraw the US New Drug Application for its anti-obesity agent after data reviewed by the Food and Drug Administration showed that while effective, it appears to double the rate of suicidal ideation and behavior (Marketletter June 18, 2007).

The drug was approved the year before its US rejection in all member states of the European Union (Marketletter July 3, 2006). The first-in-class CB1 blocker was subsequently given tougher psychiatric side effect warnings on its label (Marketletter July 30, 2007) but continued to be sold in major European markets, including the UK where the new NICE recommendation will help increase sales. However, once a strong contender for blockbuster status, last year the drug earned a disappointing 79.0 million euros ($122.6 million; Marketletter February 18).