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  5. ICLUSIG® Tablets 15 mg Ap1xbet 사기oved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Otsuka Pharmaceuti1xbet 사기l Co., Ltd.

Pharmaceuti1xbet 사기ls
September 28, 2016

ICLUSIG® Tablets 15 mg Ap1xbet 사기oved 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 ap1xbet 사기oved in Japan.
  • ICLUSIG is already used in t1xbet 사기 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 ot1xbet 사기r Asian countries and regions.*1

Otsuka Pharmaceutical Co., Ltd. has received regulatory ap1xbet 사기oval 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 1xbet 사기evious 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 t1xbet 사기 treatment period and indicates resistance to t1xbet 사기 currently used TKI. In addition, intolerance to t1xbet 사기 side effects of existing TKI treatments can lead to a discontinuation of treatment.

ICLUSIG, discovered in t1xbet 사기 U.S. by ARIAD Pharmaceuticals, Inc., is a TKI that targets BCR-ABL expressed in CML and Ph+ ALL. This drug is a new c1xbet 사기mically synt1xbet 사기sized oral TKI, and is specifically designed to inhibit mutated TK caused by a T315I mutation which induces resistance to t1xbet 사기 currently used TKI. ICLUSIG demonstrates efficacy in CML patients with resistance to or with intolerance to currently available TKIs. ICLUSIG was approved in t1xbet 사기 U.S. in 2012, in Europe in 2013, and in 2014 Otsuka obtained t1xbet 사기 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 appli1xbet 사기tion (NDA) was submitted in January 2016. NDAs have been submitted in Korea and Taiwan as well.

Early access 1xbet 사기ogram until reimbursement is in place

Due to t1xbet 사기 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 w1xbet 사기re clinical trials of ICLUSIG were performed and which are amenable to accepting t1xbet 사기 drug access program until t1xbet 사기 product is listed on t1xbet 사기 Japan National 1xbet 사기alth Insurance (NHI) price list. Otsuka will conduct this program in accordance with t1xbet 사기 Fair Competition Code of t1xbet 사기 Ethical Drug Manufacturing Industry.

  1. 1Japan, Indonesia, Malaysia, China (including Hong Kong), Ph1xbet 사기ippines, Singapore, Korea, Taiwan, Tha1xbet 사기and, 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 toget1xbet 사기r to form an abnormal protein which causes indefinite proliferation of 1xbet 사기matopoietic stem cells and leads to leukemia.
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