PRESS RELEASE: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION

for Pioglitazone/ metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets

International Nonproprietary Name (INN): pioglitazone / metformin hydrochloride

On 20 September 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal product Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets, intended for treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. The
applicant for this medicinal product is Takeda Global Research and Development Centre (Europe) Ltd.

The active substances of Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets are pioglitazone hydrochloride and metformin hydrochloride, a combination product of oral Pioglitazone hydrochloride is a thiazolidinedione and selective agonist at the PPARγ nuclear receptor and acts primarily by reducing insulin resistance in target tissues. Metformin is a biguanide and has an antihyperglycaemic effect. It is thought to act via various mechanisms, including inhibition of
gluconeogenesis in the liver, a delay in intestinal glucose absorption, and an increase in insulin sensitivity and glucose uptake in some target tissues. Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets combines these two antidiabetic agents with complimentary

The benefits with Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets are its presumed improvement of compliance by use of two antidiabetic agents in one tablet to improve glycaemic control in patients with type 2 diabetes. Common side effects are hypoglycaemia A pharmacovigilance plan for Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg filmcoated tablets, as for all medicinal products, will be implemented as part of the marketing

The approved indication is: treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been

The CHMP, on the basis of quality, safety and efficacy data of the reference product, considers that there is a favourable benefit to risk balance for Pioglitazone / metformin hydrochloride Takeda 15 mg/850 mg film-coated tablets and therefore recommends the granting of the marketing authorisation.

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