Smithkline Beecham has won its appeal against last year's rejection by the European licensing authority of its application to market rosiglitazone (Avandia), its new oral antidiabetic agent.
At its meeting last week, the Committee for Proprietary Medicinal Products, which advises the European licensing authority, recommended approval of the drug for treating type II diabetes, but only for use in combination with metformin or a sulphonylurea and in specific groups of patients.
SB says that European licensing is now expected within the next few months.
Rosiglitazone will be the only thiazolidinedione on the market, following the withdrawal of the first drug, Glaxo-Wellcome's troglitazone, in December, 1997, because of liver toxicity.