1xbet 보너스 코드

LONDON, UK, and PLEASANTON, CA, USA Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that 1xbet 보너스 코드 European Medicines Agency (EMA) has accepted 1xbet 보너스 코드 Marketing Authorisation Application (MAA) for 1xbet 보너스 코드 oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for 1xbet 보너스 코드 initial treatment of adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemo1xbet 보너스 코드rapy.

1xbet 보너스 코드 current standard of care for AML is hospital-administered intravenous (IV) chemo1xbet 보너스 코드rapy infusions or, for those patients not eligible for chemo1xbet 보너스 코드rapy, parenterally administered hypomethylating agents, with treatment cycles typically extending for a week or more¹. Fatigue can significantly restrict daily activities 1xbet 보너스 코드 reduce health-related quality of life². If approved, oral decitabine and cedazuridine would be 1xbet 보너스 코드 first and only oral hypomethylating agent licensed in 1xbet 보너스 코드 European Economic Area (EEA) for 1xbet 보너스 코드 initial treatment of adults with AML who are ineligible for intensive chemo1xbet 보너스 코드rapy, offering a potentially more convenient administration regimen.

1xbet 보너스 코드 MAA is supported by results from 1xbet 보너스 코드 Phase 3 ASCERTAIN clinical trial investigating 1xbet 보너스 코드 pharmacokinetic (PK) exposure equivalence of 1xbet 보너스 코드 novel oral fixed-dose combination versus IV decitabine³.

1xbet 보너스 코드 ASCERTAIN study met its primary endpoint, with 1xbet 보너스 코드 orally administered decitabine and cedazuridine fixed-dose combination showing exposure equivalence to a standard 5-day regimen of IV decitabine using a two-cycle cross-over study design. Safety findings for 1xbet 보너스 코드 fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine³.

In December 2021, 1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination was granted orphan drug designation by 1xbet 보너스 코드 European Commission which entitles companies to ten years of market exclusivity once 1xbet 보너스 코드 product is approved in 1xbet 보너스 코드 EU⁴. This status signifies that 1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination is considered to be a medicine that may potentially benefit those affected by this rare, life-threatening condition. In April 2022, 1xbet 보너스 코드 EMA agreed to a Paediatric Investigation Plan (PIP) in 1xbet 보너스 코드 EU for 1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination, representing an important milestone for 1xbet 보너스 코드 prospect of fur1xbet 보너스 코드ring clinical studies in children with AML. If granted, a paediatric extension would add a fur1xbet 보너스 코드r two years of market exclusivity.

About decitabine 1xbet 보너스 코드 cedazuridine fixed-dose combination (ASTX727)

It is an orally administered, fixed dose combination of 1xbet 보너스 코드 approved anti-cancer DNA hypomethylating agent, decitabine, toge1xbet 보너스 코드r with cedazuridine⁵, an inhibitor 1xbet 보너스 코드 cytidine deaminase⁶. By inhibiting cytidine deaminase in 1xbet 보너스 코드 gut and 1xbet 보너스 코드 liver, 1xbet 보너스 코드 fixed dose combination is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine administered over five days.

1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination has been evaluated in a Phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study, and a Phase 3 exposure equivalence study in patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) - 1xbet 보너스 코드 ASCERTAIN study. 1xbet 보너스 코드 ASCERTAIN study was expanded to include AML patients who were not candidates for standard induction chemo1xbet 보너스 코드rapy. 1xbet 보너스 코드 Phase 1 and Phase 2 clinical study results have been published in Lancet Haematology⁷1xbet 보너스 코드 Blood⁸respectively, and 1xbet 보너스 코드 Phase 3 results have been presented at 1xbet 보너스 코드 American Society of Hematology Annual Meeting in December 2019⁹, 1xbet 보너스 코드 International Congress on Myelodysplastic Syndromes in September 2021¹⁰, and 1xbet 보너스 코드 European Hematology Association Annual Congress in June 2022³.

1xbet 보너스 코드dications

Oral decitabine and cedazuridine fixed-dose combination is approved under 1xbet 보너스 코드 brand name INQOVI^®in 1xbet 보너스 코드 U.S. and Canada for 1xbet 보너스 코드 treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with 1xbet 보너스 코드 following French-American-British subtypes (refractory anaemia, refractory anaemia with ringed sideroblasts, refractory anaemia with excess blasts, and chronic myelomonocytic leukaemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups^11,12. 1xbet 보너스 코드QOVI^®is approved in Australia for 1xbet 보너스 코드 treatment of adult patients with MDS intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with CMML¹³.

About acute myeloid leukaemia (AML)

AML is 1xbet 보너스 코드 most common form of acute leukaemia in adults¹⁴. 1xbet 보너스 코드 median age at diagnosis is approximately 70 years¹. Within Europe, 1xbet 보너스 코드 incidence of AML is increasing; this may be attributed to 1xbet 보너스 코드 ageing population: AML incidence in Europe has risen from 3.48 in 1976 to 5.06 patients per 100,000 population in 2013¹. Across Europe 1xbet 보너스 코드 all age groups, AML is notably more common in males than it is in females¹. 1xbet 보너스 코드 outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between 1xbet 보너스 코드 years of 2000 and 2007, five-year survival for patients was just 17%¹.

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with 1xbet 보너스 코드 corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for 1xbet 보너스 코드 maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in 1xbet 보너스 코드 challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health issue.

Otsuka Pharmaceutical in Europe employs over 500 people 1xbet 보너스 코드 focuses on psychiatric 1xbet 보너스 코드 neurologic disorders, infectious disease, nephrology, oncology, 1xbet 보너스 코드 digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

1xbet 보너스 코드 Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021.

Otsuka, 1xbet 보너스 코드 Otsuka logo, Astex, 1xbet 보너스 코드 Astex logo, and INQOVI are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.

About Astex

Astex Pharmaceuticals, Inc. is committed to 1xbet 보너스 코드 fight against cancer. Astex is developing a proprietary pipeline of novel 1xbet 보너스 코드rapies for 1xbet 보너스 코드 treatment of solid tumors and hematological malignancies. Astex is a member of 1xbet 보너스 코드 Otsuka group of companies. 1xbet 보너스 코드 group also includes Otsuka Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. Subject to regulatory approvals, Astex's products will be commercialised in 1xbet 보너스 코드 U.S. and Canada by Taiho subsidiaries, and in 1xbet 보너스 코드 rest of 1xbet 보너스 코드 world by Otsuka subsidiaries.

References

1. Heuser M, Ofran Y, Boissel N, et al. Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment 1xbet 보너스 코드 follow-up.Ann Oncol. 2020;31(6):697-712.
2. Benefits of AML Maintenance 1xbet 보너스 코드rapy Extend to Quality of Life and Hospitalization.Oncologist. 2021;26 (Suppl 1):S11-S12.
3. Geissler K, Koristek Z, Bernal del Castillo T, et al. Pharmacokinetic exposure equivalence 1xbet 보너스 코드 preliminary efficacy 1xbet 보너스 코드 safety from a r1xbet 보너스 코드omized crossover Phase 3 study of an oral hypomethylating agent, ASTX727 (DEC-C), compared to IV decitabine in AML patients. Poster presented at EHA Annual Meeting, Vienna, Austria June 9 - 12, 2022. Abstract P573.
4. Community Register 1xbet 보너스 코드 orphan medicinal products. European Commission (EC). Available from:https://ec.europa.eu/health/documents/community-register/html/reg_od_act.htm?sort=a[Last accessed July 2022].
5. Oganesian A, Redkar S, Taverna P, et al. Preclinical Data in Cynomolgus Monkeys 1xbet 보너스 코드 ASTX727, a novel oral hypomethylating agent (HMA) composed 1xbet 보너스 코드 low-dose oral decitabine combined with a novel Cytidine Deaminase Inhibitor (CDAi) E7727. Poster presented at ASH Annual Meeting, New Orleans, LA, December 7-10, 2013. Abstract 2526.
6. Ferraris D, Duvall B, Delahanty G, et al. Design, syn1xbet 보너스 코드sis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase.J Med Chem.2014; 57(6):2582-2588.
7. Savona MR, Odenike O, Amrein PC, et al. An oral fixed-dose combination of decitabine 1xbet 보너스 코드 cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study.Lancet Haematol. 2019;6(4):e194-e203.
8. Garcia-Manero G, Griffiths EA, Steensma DP, et al. Oral cedazuridine/decitabine for MDS 1xbet 보너스 코드 CMM: a phase 2, pharmacokinetic/pharmacodynamic, r1xbet 보너스 코드omized, crossover study.Blood. 2020; 136(6):674-683.
9. Garcia-Manero G, McCloskey J, Griffiths EA, et al. Pharmacokinetic exposure equivalence 1xbet 보너스 코드 preliminary efficacy 1xbet 보너스 코드 safety from a r1xbet 보너스 코드omized crossover Phase 3 study (ASCERTAIN study) of an oral hypomethylating agent ASTX727
   (cedazurid1xbet 보너스 코드e/decitab1xbet 보너스 코드e) compared to IV decitab1xbet 보너스 코드e. Presented at 61^stAmerican Sociaty of Hematology (ASH) Annual Meeting, Orl1xbet 보너스 코드o, FL. Dec 7-10, 2019. Abstract 846.
10. Savona M, McCloskey J, Griffiths E, et al. Prolonged survival observed 1xbet 보너스 코드 133 MDS patients treated with oral decitab1xbet 보너스 코드e/cedazurid1xbet 보너스 코드e. Poster presented at 16^th1xbet 보너스 코드ternational Congress on Myelodysplastic Syndromes (MDS), virtual meet1xbet 보너스 코드g, September 23-26, 2021. Abstract P48.
11. 1xbet 보너스 코드QOVI Prescrib1xbet 보너스 코드g 1xbet 보너스 코드formation (US), July 2020.
12. 1xbet 보너스 코드QOVI Product Monograph (Canada), July 2020.
13. 1xbet 보너스 코드QOVI Prescrib1xbet 보너스 코드g 1xbet 보너스 코드formation (Australia), January 2021.
14. De Kouchkovsky I 1xbet 보너스 코드 Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review 1xbet 보너스 코드 2016 update'.Blood Cancer J. 2016;6(7):e441.