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News and Press Releases

August 28, 2014


Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS

No overall statistically significant increased risk of bladder cancer in patients ever exposed to pioglitazone in a completed 10-year epidemiological study


Deerfield, Ill., August 28, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour, and Welfare (MHLW) / the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl). This study was a 10-year epidemiology study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), and was designed to investigate whether patients with Type 2 diabetes who were exposed to pioglitazone were at an increased risk of bladder cancer. The completed 10-year findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.

The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer. Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone.

In the five-year interim analysis published in Diabetes Care, a statistically significant increased risk among patients with Type 2 diabetes who used pioglitazone for two or more years was observed. However, the 10-year final analysis did not show any statistically significant findings of increased risk of bladder cancer with long term use of pioglitazone. The data will be shared with additional regulatory authorities in accordance with local requirements around the world, and final results will be submitted for publication in 2014.  

“Takeda believes in the favorable clinical profile of pioglitazone,” said Charlie Baum, vice president and head, U.S. medical and scientific affairs, Takeda. “As a long-term study, these results represent a significant milestone in the history of pioglitazone, and help us better understand the benefit risk profile of our product. Patient safety is our top priority and we remain committed to the diabetes community.”

Indication for ACTOS
ACTOS (pioglitazone) is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with Type 2 diabetes. ACTOS is not for the treatment of Type 1 “juvenile” diabetes or diabetic ketoacidosis (increased ketones in blood or urine).

Important Safety Information
WARNING: HEART FAILURE
ACTOS can cause or worsen heart failure. ACTOS can cause the body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means the heart does not pump blood well enough. Patients should not take ACTOS if they have severe heart failure. If patients have heart failure with symptoms such as shortness of breath or swelling, even if these symptoms are not severe, ACTOS may not be right for them. Patients should call their doctor right away if they experience swelling or fluid retention (especially in the ankles or legs), shortness of breath or trouble breathing (especially when lying down), an unusually fast increase in weight, or unusual tiredness.

ACTOS may not be right for everyone. Serious side effects may happen to people taking ACTOS.
 
Patients should not take ACTOS if they are allergic to any of its ingredients.

ACTOS may cause liver problems. Patients should call their doctor right away if they experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes, as these could be symptoms of liver damage.

Women are at higher risk of having broken bones (fractures) while taking ACTOS.

There may be an increased chance of having bladder cancer when patients take ACTOS. Patients should not take ACTOS if they are receiving treatment for bladder cancer. Patients should tell their doctor right away if they have blood or a red color in the urine, have an increased need to urinate, or have pain while they urinate, as these may be symptoms of bladder cancer.

When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia (low blood sugar) may occur. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient’s blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some patients have experienced visual changes while taking ACTOS. If patients experience vision problems, patients should consult their doctor immediately. Patients should have their eyes checked regularly.

If a woman is of childbearing age, but does not have monthly periods, she should talk to her doctor before taking ACTOS, as it could increase her chance of becoming pregnant.

It is not known if ACTOS can harm an unborn or nursing baby. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Adverse Reactions
The most common side effects (>5%) of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.

Drug Interactions
Patients should tell their doctor about all the medicines, vitamins, and supplements they take. ACTOS and some other medicines can affect each other. Patients may need to have their dose of ACTOS or certain other medicines changed.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Complete Prescribing Information and Medication Guide for ACTOS.

About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes affecting millions of people globally. Approximately 19-20 million Americans have been diagnosed with Type 2 diabetes. Type 2 diabetes is a progressive and chronic condition and patients should work with a healthcare professional to manage and monitor their disease. Diabetes is the leading cause of kidney failure, non-traumatic lower limb amputations and new cases of blindness among adults in the United States. According to the American Diabetes Association, the United States health care expenditures for diagnosed diabetes (both Type 1 and 2) were estimated at $245 billion in 2013.

About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, and developments of other fixed-dose combinations. The company’s strong, diverse diabetes portfolio and available medications mark important milestones in Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc., located in Deerfield, Ill., is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited, Osaka, Japan. The company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines. 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 striving towards better health for people worldwide through leading innovation in medicine. Through strategic acquisitions, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach. Additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website,
www.takeda.us
.

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 people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

Contacts:

Sandy Rodriguez
Takeda Pharmaceuticals U.S.A., Inc.
(224) 554-5693

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