Otsuka files for Iclusig approval in Japan, under deal with Ariad

USA-based Ariad Pharmaceuticals (Nasdaq: ARIA) says that its partner Otsuka Pharmaceutical (TYO: 4768) has submitted a New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for Iclusig (ponatinib) for the treatment of resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL).

“The collaborative work to file this new drug application in Japan marks a significant milestone in expanding patient access to Iclusig in major geographies around the world,” said Timothy Clackson, president of R&D and chief scientific officer of Ariad, adding: “If approved, Iclusig will provide an important new treatment option for Japanese patients with refractory Philadelphia-positive leukemia.”

Ariad expects Otsuka to receive a decision on the NDA in Japan in the second half of 2016. Iclusig is approved in the USA, European Union, Australia, Switzerland, Israel and Canada. Otsuka gained rights to develop ponatinib in Japan and nine other Asian countries in December 2014.