Smithkline Beecham had a major setback last week when its new diabetes drug rosiglitazone (Avandia) was turned down by the European Committee for Proprietary Medicinal Products, the scientific advisory panel for the European licensing authority. The company declined to comment on the reasons for the CPMP's negative opinion but it described the situation as "a temporary setback" and said that it hoped the benefits of the drug would have been demonstrated to the CPMP by the end of March.
Rosiglitazone, the company's leading research drug, is already marketed in the United States. It is a thiazolidinedione compound, which acts by targeting insulin resistance, one of the underlying causes of type 2 diabetes. The drug is in the same therapeutic class as Glaxo Wellcome's troglitazone, which was suspended in the UK in 1997 after reports of hepatotoxicity. SB says that hepatotoxicity was not seen with rosiglitazone in clinical trials and has not been seen since marketing.