ZAFATEK® Now Available for the Treatment of Type 2 Diabetes in Japan

ZAFATEK® Now Available for the Treatment of Type 2 Diabetes in Japan

May 28, 2015

Important New Treatment Option is First Once Weekly Oral Option for Type 2 Diabetes Patients

Osaka, Japan, May 28, 2015 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that ZAFATEK® (generic name: trelagliptin succinate, hereafter “ZAFATEK”) is now available in Japan.
ZAFATEK is a once-weekly oral dipeptidyl peptidase-IV (DPP-4) inhibitor.

ZAFATEK controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones1 that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

The approval of ZAFATEK was granted based on the safety and efficacy results of multiple clinical phase III studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly ZAFATEK was confirmed in all studies, in addition to an acceptable safety and tolerability profile.

The prevalence of diabetes patients in Japan remains at a high level. According to the National Health and Nutrition Survey of 20122, it is estimated that there are 9.5 million people who are strongly suspected to have diabetes and 11 million people with a high possibility of having diabetes. Medication regimens for patients with type 2 diabetes are complicated and often require them to take their medicine several times a day. ZAFATEK can help patients reduce this burden by controlling blood glucose levels with convenient once-weekly dosing, contributing to improved drug adherence3.

"By adding ZAFATEK as an important new treatment option to our diabetes portfolio in Japan, we believe we are providing more suitable treatment options for the each patient's individual needs," said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. “ZAFATEK is the world's first once weekly oral type 2 diabetes treatment option. By delivering adequate information to doctors and healthcare providers, we hope ZAFATEK becomes an important therapeutic option for patients.”

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. Takeda launched alogliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i), in Japan in 2010. Since that time, alogliptin has been launched in a variety of markets across the globe including the U.S., Italy, the United Kingdom, China, Mexico and South Korea. Diabetes prevalence continues to grow worldwide, with more than 382 million people impacted by diabetes. As the disease becomes increasingly prevalent, Takeda remains focused on expanding access of alogliptin, especially in emerging markets like Brazil, Russia, and the Middle East. In 2015, Takeda launched Zafatek in Japan. Zafatek is the first ever once-weekly DPP-4i for the treatment of Type 2 diabetes. The company’s diverse diabetes portfolio of medications represent Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

1 An insulinotropic gastrointestinal hormone
2 Health, Labour and Welfare Ministry "National Health and Nutrition Survey"
3 Patients actively participate in the decision-making of treatment courses or policies, and the treatment is implemented and continued accordingly.

Product nameZAFATEK® 50mg, ZAFATEK® 100mg
Generic nametrelagliptin succinate
Indicationstype 2 diabetes
Dosage and administrationUsually, for adults, 100 mg of trelagliptin is orally administered once a week
NHI Drug Price50mg: 559.2 yen, 100mg: 1045.1 yen



Tsuyoshi Tada
Takeda Pharmaceutical Company Limited
E-mail: [email protected]