Avandia, SmithKline Beecham's new thiazolidinedione or "insulin-sensitizer" for the treatment of hyperglycemia in patients with type II diabetes, has been recommended for approval by the Food and Drug Administration's Endocrinologic and Metabolic Advisory Committee. The FDA, which usually follows its advisory panel's recommendations, is expected to decide whether to approve Avandia in late May.
Based on the data presented, panel members voted to approve the drug as monotherapy and in combination with metformin. The drug belongs to the same class as Rezulin but doesn't appear to cause the same liver toxicities. The FDA now recommends that Rezulin patients receive monthly liver tests during their first eight months of therapy. Panel members, however, stressed that labels of all drugs in this new class should recommend liver monitoring.
If the drug is approved, it will almost certainly set off a major marketing battle between SmithKline Beecham and Warner-Lambert, the manufacturer of Rezulin, which has had sales of more than $1 billion since its launch in 1997. SmithKline announced it had entered into an agreement with Bristol-Myers Squibb, which markets the No. 1 diabetes drug worldwide, Glucophage, to market Avandia, hoping to take advantage of Bristol-Myers Squibb's seasoned marketing team in the diabetes category.
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