Further European Regulatory Review Clarifies and Confirms Prior CHMP Position on Positive Benefit-Risk Balance for Pioglitazone-Containing Products

Takeda Pharmaceutical Company Limited announced that at the request of the European Commission (EC), the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP) has clarified the label changes for pioglitazone-containing medicines recommended in July of this year. The updated opinion has been submitted to the European Commission and the EMA has indicated they expect it to be adopted by the Commission within the next two to three months.

In July this year, following a review under Article 20 of Regulation (EC) No. 726/2004, the CHMP concluded that pioglitazone-containing medicines remain a valid treatment option for certain patients with type 2 diabetes. While a small increased risk of bladder cancer has

been identified in patients taking these medicines, the CHMP concluded that this risk could be reduced by appropriate patient selection and exclusion, updated contraindications and warnings in the product labels, and periodic review of the efficacy and safety of the patient’s treatment.

During the European Commission decision-making procedure arising from the CHMP opinion adopted on 21 July 2011, the Commission requested that the CHMP clarify the product indications. Takeda has agreed to this clarification wording with the CHMP. This

clarifying wording does not change the intended usage of pioglitazone-containing products in clinical practice and provides additional clarification for physicians on the correct setting for pioglitazone.

The CHMP initiated the European review of pioglitazone-containing medicines to investigate the signal of a possible increased risk of bladder cancer with pioglitazone use. In making their recommendation, the CHMP reviewed all available data on the occurrence of bladder cancer, including results of preclinical studies, clinical studies, epidemiological studies and spontaneous reports, to assess the balance of benefits and risks of these medicines. The Committee also considered the advice from its Scientific Advisory Group (SAG) on


Takeda remains confident in the therapeutic benefits of pioglitazone as an important treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications, and to the millions of people living with type 2 diabetes. The company will continue to make these products available so that patients can benefit from them. Takeda recommends that any patients taking pioglitazone-containing medications consult their health care provider if they have any questions. Takeda has consistently emphasized the importance of physician education and patient safety with pioglitazone, and has prioritized communicating the appropriate use of pioglitazone in patients with type 2 diabetes.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.