French drugmaker Sanofi-Aventis said on Wednesday, June 25, that it has won final backing for its obesity drug Acomplia from UK advisory panel NICE, clearing the way for doctors to prescribe it on the state health service.
The London-based National Institute for Health and Clinical Excellence’s final guidance recommends using Acomplia as an addition to diet and exercise for obese or overweight adults who don't respond to or are intolerant of two other weight-loss drugs, orlistat and sibutramine.
However, NICE has cautioned that the drug should not be used for longer than six months unless a patient loses at least five percent of his or her body weight and not for longer than two years without individual risk assessment.
The recommendation means the National Health Service may cover the pill for patients.
US approval
Acomplia was rejected by a U.S. Food and Drug Administration panel last year after it was linked to rare cases of suicidal thoughts. It was touted as a multibillion-dollar seller.
Sanofi said in October it expected only limited sales of the drug in the next few years, until new clinical trial results testing it in diabetes are ready for submission to regulators in 2009.
Worldwide sales of the drug were €79million last year.
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