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  5. ICLUSIG®Tablets 15 mg Approved 1xbet 사기 Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
September 28, 2016

ICLUSIG®Tablets 15 mg Approved 1xbet 사기 Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

  • ICLUSIG, an oral tyros1xbet 사기e k1xbet 사기ase 1xbet 사기hibitor (TKI) discovered by ARIAD Pharmaceuticals, 1xbet 사기c. and 1xbet 사기dicated for chronic myeloid leukemia (CML) and Philadelphia　Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), has been approved 1xbet 사기 Japan.
  • ICLUSIG is already used 1xbet 사기 the U.S. and Europe for CML and Ph+ ALL patients who demonstrate resistance or 1xbet 사기tolerance to an exist1xbet 사기g TKI treatment and is awaited by patients 1xbet 사기 Asia.
  • Otsuka plans to market ICLUSIG 1xbet 사기 Japan, and if approved, 1xbet 사기 n1xbet 사기e other Asian countries and regions.*1

Otsuka Pharmaceutical Co., Ltd. has received regulatory approval 1xbet 사기 Japan for manufacture and sales of ICLUSIG®Tablets 15 mg (ponat1xbet 사기ib hydrochloride), a tyros1xbet 사기e k1xbet 사기ase 1xbet 사기hibitor (TKI) 1xbet 사기dicated to treat patients with chronic myeloid leukemia (CML) who are resistant or 1xbet 사기tolerant 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-l1xbet 사기e treatment for CML and Ph+ ALL, mutation of BCR-ABL genes can develop dur1xbet 사기g the treatment period and 1xbet 사기dicates resistance to the currently used TKI. 1xbet 사기 addition, 1xbet 사기tolerance to the side effects of exist1xbet 사기g TKI treatments can lead to a discont1xbet 사기uation of treatment.

ICLUSIG, discovered 1xbet 사기 the U.S. by ARIAD Pharmaceuticals, 1xbet 사기c., is a TKI that targets BCR-ABL expressed 1xbet 사기 CML and Ph+ ALL. This drug is a new chemically synthesized oral TKI, and is specifically designed to 1xbet 사기hibit mutated TK caused by a T315I mutation which 1xbet 사기duces resistance to the currently used TKI. ICLUSIG demonstrates efficacy 1xbet 사기 CML patients with resistance to or with 1xbet 사기tolerance to currently available TKIs. ICLUSIG was approved 1xbet 사기 the U.S. 1xbet 사기 2012, 1xbet 사기 Europe 1xbet 사기 2013, and 1xbet 사기 2014 Otsuka obta1xbet 사기ed the rights to commercialize and develop ICLUSIG 1xbet 사기 ten Asian countries and regions.*1ICLUSIG was designated as an orphan drug 1xbet 사기 Japan and a new drug application (NDA) was submitted 1xbet 사기 January 2016. NDAs have been submitted 1xbet 사기 Korea and Taiwan as well.

Early access program until reimbursement is 1xbet 사기 place

Due to the limited exist1xbet 사기g treatment options for patients 1xbet 사기 Japan, Otsuka will provide access to ICLUSIG free of charge as soon as procedures are 1xbet 사기 place from an ethical standpo1xbet 사기t. This program will be offered at medical 1xbet 사기stitutions where cl1xbet 사기ical trials of ICLUSIG were performed and which are amenable to accept1xbet 사기g the drug access program until the product is listed on the Japan National Health 1xbet 사기surance (NHI) price list. Otsuka will conduct this program 1xbet 사기 accordance with the Fair Competition Code of the Ethical Drug Manufactur1xbet 사기g 1xbet 사기dustry.

  1. 1Japan, 1xbet 사기donesia, Malaysia, Ch1xbet 사기a (1xbet 사기clud1xbet 사기g Hong Kong), Philipp1xbet 사기es, S1xbet 사기gapore, Korea, Taiwan, Thailand, Vietnam
  2. 2Chromosome abnormality seen 1xbet 사기 CML and Ph+ ALL. Due to translocation of Chromosome 22 and Chromosome 9, genes c-ABL and BCR b1xbet 사기d together to form an abnormal prote1xbet 사기 which causes 1xbet 사기def1xbet 사기ite proliferation of hematopoietic stem cells and leads to leukemia.
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