Takeda's Tandemact approved by EMEA

Osaka, Japan-based Takeda Pharmaceutical says that it has been granted European marketing authorization for the diabetes treatment Tandemact (pioglitazone HCl and glimepride HCl). The agent is intended for the treatment of patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already being treated with a combination of the two active ingredients.

Tandemact was filed with the European Medicines Agency (EMEA) by the company's European unit, Takeda Global Research and Development Center (TGRD) in July 2005, and was the subject of a positive opinion from the EMEA's Committee for Medicinal Products for Human use.

The company added that the drug combines the active component of the firm's insulin sensitization product Actos (pioglitazone) with a sulfonylurea-based compound, and is designed to both improve the response to, and upregulate the production of, insulin. Two dosage strengths have been approved, 30mg/4mg and 45mg/4mg.