New Indication for Hyperuricemia Drug in Europe

Teijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, has announced that the Menarini Group, a sublicensee of its European partner Ipsen, has received approval in Europe for an expanded indication for ADENURIC® (febuxostat), a novel drug for the treatment of hyperuricemia and gout. The indication is prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumour lysis syndrome (TLS).

The expanded indication is based on positive results achieved in a phase 3 clinical trial involving 346 patients exhibiting intermediate to high risk of TLS. The trial proved that febuxostat has important clinical significance and high potential for treatment compared to existing options. As a result, the Menarini Group has been allowed to extend its marketing protection period for an additional year, until April 20, 2019.

In the meantime, Teijin Pharma is conducting a phase 3 clinical trial of febuxostat for hyperuricemia associated with a malignant tumour receiving chemotherapy. The drug will provide an alternative to allopurinol, the current standard of care used in Europe and the option rasburicase, a uric acid-degrading enzyme rasburicaseis, used in Europe mainly for patients with high-risk of TLS. Under these conditions, new treatment options have been in demand, said Teijin.