Daiichi Sankyo Gains Diabetes Indication For Cholesterol Drug WelChol
This article was originally published in The Pink Sheet Daily
Executive Summary
Therapy indicated as adjunctive treatment to improve glycemic control in type 2 diabetes patients.
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Daiichi Sankyo received sNDA approval for its cholesterol drug WelChol (colesevelam) as an adjunct therapy to improve glycemic control in patients with type 2 diabetes Jan. 18. The product is the first LDL-lowering medication also indicated for improving glycemic control. In an interview last summer with "The Pink Sheet" DAILY, Daiichi Sankyo U.S. CEO Joe Pieroni said he expected that the favorable safety profile of WelChol - which is not absorbed by the body - would help differentiate the product from other therapies in the crowded diabetes market (1 (Also see "Daiichi Sankyo U.S. CEO Joe Pieroni: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 3 Aug, 2007.)). The company announced it had submitted an sNDA seeking the expanded claim in January 2007 (2 (Also see "Daiichi Sankyo Submits WelChol sNDA For Diabetes Indication" - Pink Sheet, 2 Jan, 2007.)). The submission was based on three double-blind, placebo-controlled add-on therapy studies involving 1,018 type 2 diabetes patients taking WelChol 3.8 g/day. WelChol and placebo were administered either as three tablets twice daily with lunch and dinner or as six tablets with dinner alone. In all three studies, treatment with WelChol resulted in a statistically significant reduction in A1C of 0.5 percent compared to placebo. WelChol, a bile acid sequestrant, was approved by FDA for LDL-C lowering alone or in combination with a statin in May 2000. The drug is marketed in Europe as Cholestagel by Genzyme. -Brooke McManus ([email protected]) |