An FDA advisory committee unanimously endorsed approval for marketing of rosiglitazone (Avandia, SmithKline Beecham) and concluded that pioglitazone (Actos, Takeda) is safe (the panel did not review efficacy of pioglitazone). Even though no cases of liver failure or toxicity have been reported with either drug, the panel recommended inclusion of warnings in their labeling that would suggest periodic liver tests because of problems with troglitazone (Rezulin, Parke-Davis).
Separately, SKB strengthened its hand by announcing it would copromote rosiglitazone – likely to be approved for treatment of patients with diabetes type 2 as either monotherapy or with metformin – with Bristol-Myers Squibb, which markets metformin (Glucophage). Since rosiglitazone will probably reach the U.S. market before pioglitazone, the collaboration could be critical in quickly penetrating the insulin-resistance market. Some experts project that pioglitazone will become the market leader in the glitazone class, and Takeda’s previously announced marketing collaboration with Lilly promises to make the competition fierce.