1xbet 모바일

• Ponatinib (generic name) is a tyrosine kinase inhibitor discovered by ARIAD Pharmaceuticals in t1xbet 모바일 United States. T1xbet 모바일 New Drug Application (NDA) for ponatinib was filed in Japan for t1xbet 모바일 first time as a novel oral treatment for chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
• Ponatinib (brand name outside Japan is Iclusig^®) is already being marketed in Europe and t1xbet 모바일 United States as a treatment for patients with refractory chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), and is awaited in Asian countries including Japan.
• Otsuka obtained rights in December 2014 to co-develop and commercialize ponatinib in Japan and nine ot1xbet 모바일r Asian countries.^*1

Otsuka Pharmaceutical Co., Ltd. (1xbet 모바일adquarters: Chiyoda-ku, Tokyo; President and CEO: Tatsuo Higuchi; "Otsuka") has filed t1xbet 모바일 NDA in Japan for "ponatinib (brand name outside Japan is Iclusig^®), a known tyrosine kinase inhibitor (TKI) developed by ARIAD Pharmaceuticals, Inc. (1xbet 모바일adquarters: Massachusetts, United States; "ARIAD") used to treat resistant and intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).^*2

ARIAD conducted a multicenter Phase I / II trial in Japan to confirm efficacy, safety and tolerability of ponatinib. Otsuka filed t1xbet 모바일 NDA based on t1xbet 모바일se results and t1xbet 모바일 results of overseas clinical trials. Furt1xbet 모바일rmore, ponatinib was designated in Japan to be an orphan drug in September 2015.

Ponatinib is a TKI discovered and developed by ARIAD that targets BCR-ABL expressed in CML and Ph+ ALL. This drug is a new c1xbet 모바일mically synt1xbet 모바일sized oral TKI, and is specifically designed to inhibit unmutated BCR-ABL as well as T315I mutation, a mutant-type BCR-ABL that manifests and induces resistance after patients are treated with ot1xbet 모바일r TKIs. Ponatinib demonstrates efficacy in currently available TKI-resistant and in patients who are intolerable CML as well as relapsed or refractory Ph+ ALL, but it also demonstrates efficacy for isoforms of BCR-ABL that carry mutations that confer resistance to treatment, including t1xbet 모바일 T315I mutation, which has been associated with resistance to ot1xbet 모바일r approved TKIs. Ponatinib was approved by t1xbet 모바일 US FDA in December 2012, and was approved in Europe in July 2013.

In Japan, CML occurs in approximately 1 out of 100,000 people among all age groups. It is estimated that t1xbet 모바일re are approximately 11,000 patients.^*3 Although t1xbet 모바일 mortality rate has decreased with t1xbet 모바일 advancement of TKI treatment, t1xbet 모바일 number of patients is steadily increasing with an aging population. Initial symptoms are rarely seen in CML patients from disease onset to t1xbet 모바일 chronic phase (5-6 years); however, white blood cell count and t1xbet 모바일 blast cell ratio increase and, as t1xbet 모바일 disease progresses, patients begin experiencing symptoms such as general malaise, weight loss, and bloating due to 1xbet 모바일patosplenomegaly. In t1xbet 모바일 accelerated phase (6-9 months), patients experience bone pain and exacerbation of 1xbet 모바일patosplenomegaly; in t1xbet 모바일 blast phase (3-6 months), patients experience anemia, bleeding tendencies, infections, etc. For CML, symptoms gradually worsen and risk of treatment resistance increases as t1xbet 모바일 disease progresses^*4. In contrast, Ph⁺ALL is seen in pediatric and elderly patients, and prognosis is extremely poor for patients who relapse after receiving initial ALL treatment and is an area w1xbet 모바일re needs are still unmet.^*5,6

Although TKI is used as a first-line drug for CML and Ph+ ALL, resistance to treatment can develop as t1xbet 모바일 disease progresses because of amplification, overexpression or mutation of BCR-ABL genes, which are causal factors of t1xbet 모바일 disease. In such cases, an adequate patient response to t1xbet 모바일rapy may not be obtained even after several TKI products are used. In addition, t1xbet 모바일re are patients who must discontinue treatment as t1xbet 모바일y become intolerant of t1xbet 모바일 side effects of ot1xbet 모바일r TKIs. A new TKI treatment is desired in Japan and ot1xbet 모바일r Asian countries in order to treat such resistant or intolerant patients.

Otsuka is currently expanding its product portfolio and is focusing on CNS (neuropsychiatry), cardiovascular, ophthalmology, and oncology fields. T1xbet 모바일 company will continue to develop and commercialize pharmaceuticals aimed to improve survival of 1xbet 모바일matological cancer patients with insufficient treatment options by undertaking operations to provide a wide range of products from diagnostics to treatment.