Takeda’s Combo Duetact Will Launch Later This Year For Type 2 Diabetes
This article was originally published in The Pink Sheet Daily
Executive Summary
Takeda's existing Actos sales force will detail the pioglitazone and glimepiride combination therapy to primary care physicians.
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Takeda will launch a fixed-dose combination of Actos (pioglitazone HCl) and the sulfonylurea glimepiride (Sanofi-Aventis' Amaryl and generics) as Duetact later this year, the company told "The Pink Sheet" DAILY July 31. FDA cleared the fixed-dose combination as a second-line type 2 diabetes treatment July 28. The drug is indicated "as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control," according to labeling. Takeda will launch Duetact under its existing 1,250-member sales team, which already sells Actos and Actos Plus Met , a pioglitazone and metformin combination. Approximately 1,000 reps will detail Duetact, primarily targeting primary care physicians who are at the front lines in diagnosing the disease and who "are familiar not only with Actos but also sulfonylureas," Takeda said. "Combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease," the company added. Duetact will be available in two commonly used dosages of pioglitazone and glimepiride, 30 mg/2 mg and 30 mg/4 mg. The approval was based on the established efficacy of pioglitazone and glimepiride, as well as two randomized controlled clinical studies in patients with type 2 diabetes who were administered pioglitazone plus a sulfonylurea. Based on reductions in A1C and FPG in the two studies, "the addition of pioglitazone to sulfonylurea resulted in significant improvements in glycemic control irrespective of the sulfonylurea dosage," labeling says. Labeling for Duetact includes a bolded warning advising of an increased risk of cardiovascular mortality as compared to treatment with diet alone or diet plus insulin, based on a University Group Diabetes Program study. Glimepiride is also currently included in a fixed-dose combination with rosiglitazone in GlaxoSmithKline's Avandaryl . Generic versions of glimepiride were launched last year following the expiration of Sanofi-Aventis' patent exclusivity (1 (Also see "Amaryl Generics Hit The Market, Led By Prasco's "Authorized" Product" - Pink Sheet, 6 Oct, 2005.)). -Jessica Merrill |