Competact Diabetes Drug Withdrawn As EU Is Unlikely To Approve
Takeda Pharmaceutical Company Limited recently withdrew their application to market its type 2 diabetes treatment drug, Competact, in Europe. Takeda has also decided to stop the continuing development of the prolonged-release formula. The source for discontinuing the drug is due to lack of data.
Discussions with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) resulted in them not finding a “formal positive opinion” because more information was needed.
The comments involve only the Competact prolonged-released formulation or once daily dosing treatment, not the immediate-release formulation, which is taken twice daily. The latter drug was approved by the EU in July 2006 and is a widely used option for type 2 diabetes drug treatment.
Takeda's press release states “The discontinuation of a prolonged-release formulation will not influence the projected results for the 2009 fiscal year.”
The biotech company is responsible for the development of Actos (pioglitazone), a thiazolidinedione derivative (TZD) that directly targets insulin resistance. Actos combines TZDs with metformin, which reduces the amount of glucose produced in the liver.
“The combination tablet of pioglitazone HCl with immediate-release metformin HCl was also approved in U.S. in August 2005 and is currently marketed under the brand name of ACTOplus met and the New Drug Application of the combination tablet of pioglitazone HCl with immediate-release metformin HCl was submitted in Japan to the Ministry of Health, Labour and Welfare in October 2008 and is now under review.”