Takeda submits NDA for extended-release ActoPlus

by | 4th Apr 2006 | News

Takeda Global Research & Development Center is seeking permission from US regulators to market an extended-release version of its combination type 2 diabetes drug, ActoPlus met (pioglitazone and metformin).

Takeda Global Research & Development Center is seeking permission from US regulators to market an extended-release version of its combination type 2 diabetes drug, ActoPlus met (pioglitazone and metformin).

This new formulation, called ActoPlus met XR, contains US group Andrx’ extended-release metformin and offers the advantage of once-daily dosing. Its immediate-release predecessor, ActoPlus met, is already available in the USA, where it is sold by Takeda Pharmaceuticals North America.

Commenting on the drug’s potential, John Yates, President of TGR&D, explained: “Not all patients are alike, especially in diabetes, and the addition of this new product would provide patients and their physicians with more options and greater flexibility, while continuing to provide the benefits of treatment with Actos.”

Actoplus Met combines Eli Lilly and Takeda’s Actos (pioglitazone) with the generic sulfonylurea metformin, and is designed to combat diabetes via two mechanisms: by directly targeting insulin resistance and by reducing the amount of glucose produced by the liver. A spokesman for Takeda, Ralph DeFronzo, chief of the diabetes division at the University of Texas Health Science Center at San Antonio, commented: “Within three years of being prescribed their first medication, approximately 50% of patients will need to add additional therapies to manage their condition.”

Tags


Related posts