
Home > Newsroom > 2003 > Actos Approved for Monotherapy for Defined Patients with Type 2 Diabetes in Europe
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September 3, 2003
OSAKA, JAPAN, September 3, 2003 --- Takeda Chemical Industries, Ltd. ("Takeda") announced today that European Commission has granted to Takeda Europe Research & Development Centre, Ltd., London, a wholly owned subsidiary of Takeda, and Eli Lilly Company ("Lilly"), a marketing authorization for the use of Actos (pioglitazone) as oral monotherapy at doses up to 45 mg in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
"The approval of the EU monotherapy indication is excellent news for physicians and patients," said Professor David Matthews, Professor of Diabetic Medicine, University of Oxford. "Many patients require a treatment approach that addresses one of the universal features of type 2 diabetes - namely insulin resistance. Giving therapies that sensitize the body to insulin is one logical approach, reducing both excess insulin levels and elevated fasting plasma glucose."
"The approval of ACTOS for monotherapy is a significant step forward in the treatment of type 2 diabetes," added Dr.David Eckland, Managing Director of Takeda Europe R&D Centre, Ltd., London, UK. "There is a growing realization among physicians that improving glycaemic control alone is not enough. Researchers believe most cases of type 2 diabetes have insulin resistance which is a potential link between metabolic abnormalities and diabetic vascular complications - it is therefore critical to reduce insulin resistance."
Takeda is the originator of thiazolidinedione derivatives and Actosa is a member of the thiazolidinedione class of "insulin-sensitizing" agents. Actosa has been prescribed to over 4 million patients in more than 60 countries to date. Takeda has licensed Lilly to market Actosa in a number of countries around the world.
Takeda is a global research-based pharmaceutical company, largest in Japan and one of the leaders in the world. Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
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