Teijin Pharma’s FEBURIC (Febuxostat) Approved As Indication For Cancer Chemotherapy-Induced Hyperuricemia

Published: May 23, 2016

Tokyo, Japan, May 23, 2016 --- Teijin Pharma Limited announced today that FEBURIC® (febuxostat), a novel drug developed by Teijin Pharma for the treatment of hyperuricemia with or without gout, has been approved by Japan's Ministry of Health, Labour and Welfare as an indication for hyperuricemia caused by cancer chemotherapy.

Febuxostat, currently sold in 57 countries, is expected to be made available in 117 markets in regions including North America, Europe and Asia. It is currently marketed as ADENURIC® in Europe, where it was approved in April 2015 for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).

Going forward, Teijin Pharma aims to expand febuxostat’s global development to enhance the treatment of hyperuricemia and improve the quality of life for patients.

Febuxostat, a highly potent oral drug taken once daily, is indicated for the treatment of hyperuricemia with or without gout and available in 10mg, 20mg, and 40mg tablets under the brand name of FEBURIC® in Japan. The normal maintenance dose is 40mg taken orally once daily and the maximum dose is 60mg. The newly approved indication in Japan for hyperuricemia caused by cancer chemotherapy is 60mg taken orally once daily.

Cancer chemotherapy can rapidly destroy large quantities of cancer cells, leading to high amounts of nucleic acids and electrolytes being released into the blood. Nucleic acids are degraded and metabolized as uric acid, and if the amount is excessive it can lead to hyperuricemia or acute renal failure. Until now, the only pharmaceutical in Japan indicated for hyperuricemia due to cancer chemotherapy has been an enzyme preparation for the decomposition of urate, so additional treatment options have been in high demand. Teijin Pharma, researching febuxostat’s inhibitory effect for uric acid production, initiated a phase 3 clinical trial to examine the efficacy and safety of a 60mg dose for cancer chemotherapy patients with malignant tumors. The company applied for this additional indication in July 2015.

About the Teijin Group

Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of sustainable transportation, information and electronics, safety and protection, environment and energy, and healthcare. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 150 companies and around 16,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY790.7 billion (USD 7.4 billion) and total assets of JPY 823.4 billion (USD 7.7 billion) in the fiscal year ending March 31, 2016. Please visit www.teijin.com.

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