Otsuka Pharmaceutical Co., Ltd.

September 28, 2016

ICLUSIG® Tablets 15 mg Approved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

  • ICLUSIG, an oral tyrosine kinase inhibitor (TKI) discovered by ARIAD Pharmaceuticals, Inc. and indicated for chronic myeloid leukemia (CML) and Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), has been approved in Japan.
  • ICLUSIG is already used in the U.S. and Europe for CML and Ph+ ALL patients who demonstrate resistance or intolerance to an existing TKI treatment and is awaited by patients in Asia.
  • Otsuka plans to market ICLUSIG in Japan, and if approved, in nine other Asian countries and regions.*1

Otsuka Pharmaceutical Co., Ltd. has received regulatory approval in Japan for manufacture and sales of ICLUSIG® Tablets 15 mg (ponatinib hydrochloride), a tyrosine kinase inhibitor (TKI) indicated to treat patients with chronic myeloid leukemia (CML) who are resistant or intolerant to previous treatments and patients with recurrent or refractory Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).*2

Although TKIs are used as a first-line treatment for CML and Ph+ ALL, mutation of BCR-ABL genes can develop during the treatment period and indicates resistance to the currently used TKI. In addition, intolerance to the side effects of existing TKI treatments can lead to a discontinuation of treatment.

ICLUSIG, discovered in the U.S. by ARIAD Pharmaceuticals, Inc., is a TKI that targets BCR-ABL expressed in CML and Ph+ ALL. This drug is a new chemically synthesized oral TKI, and is specifically designed to inhibit mutated TK caused by a T315I mutation which induces resistance to the currently used TKI. ICLUSIG demonstrates efficacy in CML patients with resistance to or with intolerance to currently available TKIs. ICLUSIG was approved in the U.S. in 2012, in Europe in 2013, and in 2014 Otsuka obtained the rights to commercialize and develop ICLUSIG in ten Asian countries and regions.*1 ICLUSIG was designated as an orphan drug in Japan and a new drug application (NDA) was submitted in January 2016. NDAs have been submitted in Korea and Taiwan as well.

Early access program until reimbursement is in place

Due to the limited existing treatment options for patients in Japan, Otsuka will provide access to ICLUSIG free of charge as soon as procedures are in place from an ethical standpoint. This program will be offered at medical institutions where clinical trials of ICLUSIG were performed and which are amenable to accepting the drug access program until the product is listed on the Japan National Health Insurance (NHI) price list. Otsuka will conduct this program in accordance with the Fair Competition Code of the Ethical Drug Manufacturing Industry.

  1. 1Japan, Indonesia, Malaysia, China (including Hong Kong), Philippines, Singapore, Korea, Taiwan, Thailand, Vietnam
  2. 2Chromosome abnormality seen in CML and Ph+ ALL. Due to translocation of Chromosome 22 and Chromosome 9, genes c-ABL and BCR bind together to form an abnormal protein which causes indefinite proliferation of hematopoietic stem cells and leads to leukemia.