Teijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, announced today, 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 tumor 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 tumor receiving chemotherapy.
For more details, go to: http://www.teijin-pharma.com/information/2015/20150630.html