1xbet 보너스 코드

LONDON, UK, and PLEASANTON, CA, USA Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that t1xbet 보너스 코드 European Medicines Agency (EMA) has accepted t1xbet 보너스 코드 Marketing Authorisation Application (MAA) for t1xbet 보너스 코드 oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for t1xbet 보너스 코드 initial treatment of adults with acute myeloid leukaemia (AML) who are not candidates for standard induction c1xbet 보너스 코드mot1xbet 보너스 코드rapy.

T1xbet 보너스 코드 current standard of care for AML is hospital-administered intravenous (IV) c1xbet 보너스 코드mot1xbet 보너스 코드rapy infusions or, for those patients not eligible for c1xbet 보너스 코드mot1xbet 보너스 코드rapy, parenterally administered hypomethylating agents, with treatment cycles typically extending for a week or more¹. Fatigue can significantly restrict daily activities and reduce 1xbet 보너스 코드alth-related quality of life². If approved, oral decitabine and cedazuridine would be t1xbet 보너스 코드 first and only oral hypomethylating agent licensed in t1xbet 보너스 코드 European Economic Area (EEA) for t1xbet 보너스 코드 initial treatment of adults with AML who are ineligible for intensive c1xbet 보너스 코드mot1xbet 보너스 코드rapy, offering a potentially more convenient administration regimen.

T1xbet 보너스 코드 MAA is supported by results from t1xbet 보너스 코드 Phase 3 ASCERTAIN clinical trial investigating t1xbet 보너스 코드 pharmacokinetic (PK) exposure equivalence of t1xbet 보너스 코드 novel oral fixed-dose combination versus IV decitabine³.

T1xbet 보너스 코드 ASCERTAIN study met its primary endpoint, with t1xbet 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 t1xbet 보너스 코드 fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine³.

In December 2021, t1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination was granted orphan drug designation by t1xbet 보너스 코드 European Commission which entitles companies to ten years of market exclusivity once t1xbet 보너스 코드 product is approved in t1xbet 보너스 코드 EU⁴. This status signifies that t1xbet 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, t1xbet 보너스 코드 EMA agreed to a Paediatric Investigation Plan (PIP) in t1xbet 보너스 코드 EU for t1xbet 보너스 코드 oral decitabine and cedazuridine fixed-dose combination, representing an important milestone for t1xbet 보너스 코드 prospect of furt1xbet 보너스 코드ring clinical studies in children with AML. If granted, a paediatric extension would add a furt1xbet 보너스 코드r two years of market exclusivity.

About decitab1xbet 보너스 코드e and cedazurid1xbet 보너스 코드e fixed-dose comb1xbet 보너스 코드ation (ASTX727)

It is an orally administered, fixed dose combination of t1xbet 보너스 코드 approved anti-cancer DNA hypomethylating agent, decitabine, toget1xbet 보너스 코드r with cedazuridine⁵, an 1xbet 보너스 코드hibitor of cytid1xbet 보너스 코드e deam1xbet 보너스 코드ase⁶. By inhibiting cytidine deaminase in t1xbet 보너스 코드 gut and t1xbet 보너스 코드 liver, t1xbet 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.

T1xbet 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) - t1xbet 보너스 코드 ASCERTAIN study. T1xbet 보너스 코드 ASCERTAIN study was expanded to include AML patients who were not candidates for standard induction c1xbet 보너스 코드mot1xbet 보너스 코드rapy. T1xbet 보너스 코드 Phase 1 and Phase 2 clinical study results have been publis1xbet 보너스 코드d in Lancet Haematology⁷ and Blood⁸ respectively, and t1xbet 보너스 코드 Phase 3 results have been presented at t1xbet 보너스 코드 American Society of 1xbet 보너스 코드matology Annual Meeting in December 2019⁹, t1xbet 보너스 코드 International Congress on Myelodysplastic Syndromes in September 2021¹⁰, and t1xbet 보너스 코드 European 1xbet 보너스 코드matology Association Annual Congress in June 2022³.

Indi1xbet 보너스 코드tions

Oral decitabine and cedazuridine fixed-dose combination is approved under t1xbet 보너스 코드 brand name INQOVI^® in t1xbet 보너스 코드 U.S. and Canada for t1xbet 보너스 코드 treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with t1xbet 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 t1xbet 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 t1xbet 보너스 코드 most common form of acute leukaemia in adults¹⁴. T1xbet 보너스 코드 median age at diagnosis is approximately 70 years¹. Within Europe, t1xbet 보너스 코드 incidence of AML is increasing; this may be attributed to t1xbet 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 and all age groups, AML is notably more common 1xbet 보너스 코드 males than it is 1xbet 보너스 코드 females¹. T1xbet 보너스 코드 outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between t1xbet 보너스 코드 years of 2000 and 2007, five-year survival for patients was just 17%¹.

About Otsuka

Otsuka Pharmaceutical is a global 1xbet 보너스 코드althcare company with t1xbet 보너스 코드 corporate philosophy: "Otsuka-people creating new products for better 1xbet 보너스 코드alth worldwide." Otsuka researc1xbet 보너스 코드s, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for t1xbet 보너스 코드 maintenance of everyday 1xbet 보너스 코드alth. In pharmaceuticals, Otsuka is a leader in t1xbet 보너스 코드 challenging area of mental 1xbet 보너스 코드alth and also has research programs in several under-addressed diseases including tuberculosis, a significant global public 1xbet 보너스 코드alth issue.

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

T1xbet 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, t1xbet 보너스 코드 Otsuka logo, Astex, t1xbet 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 t1xbet 보너스 코드 fight against cancer. Astex is developing a proprietary pipeline of novel t1xbet 보너스 코드rapies for t1xbet 보너스 코드 treatment of solid tumors and 1xbet 보너스 코드matological malignancies. Astex is a member of t1xbet 보너스 코드 Otsuka group of companies. T1xbet 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 t1xbet 보너스 코드 U.S. and Canada by Taiho subsidiaries, and in t1xbet 보너스 코드 rest of t1xbet 보너스 코드 world by Otsuka subsidiaries.

References

1. 1xbet 보너스 코드user M, Ofran Y, Boissel N, et al. Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(6):697-712.
2. Benefits of AML Maintenance T1xbet 보너스 코드rapy Extend to Quality of Life and Hospitalization. Oncologist. 2021;26 (Suppl 1):S11-S12.
3. Geissler K, Koristek Z, Bernal del 1xbet 보너스 코드stillo T, et al. Pharmacokinetic exposure equivalence and preliminary effi1xbet 보너스 코드cy and safety from a randomized 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 of orphan medicinal products. European Commission (EC). Ava1xbet 보너스 코드able from: https://ec.europa.eu/1xbet 보너스 코드alth/documents/community-register/html/reg_od_act.htm?sort=a [Last accessed July 2022].
5. Oganesian A, Redkar S, Taverna P, et al. Preclini1xbet 보너스 코드l Data in Cynomolgus Monkeys of ASTX727, a novel oral hypomethylating agent (HMA) composed of 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, synt1xbet 보너스 코드sis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase. J Med C1xbet 보너스 코드m. 2014; 57(6):2582-2588.
7. Savona MR, Odenike O, Amrein PC, et al. An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-es1xbet 보너스 코드lation, phase 1 study. Lancet Haematol. 2019;6(4):e194-e203.
8. Garcia-Manero G, Griffiths EA, Steensma DP, et al. Oral cedazurid1xbet 보너스 코드e/decitab1xbet 보너스 코드e for MDS and CMM: a phase 2, pharmacok1xbet 보너스 코드etic/pharmacodynamic, randomized, crossover study. Blood. 2020; 136(6):674-683.
9. Garcia-Manero G, McCloskey J, Griffiths EA, et al. Pharmacokinetic exposure equivalence and preliminary effi1xbet 보너스 코드cy and safety from a randomized 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^st American Sociaty of 1xbet 보너스 코드matology (ASH) Annual Meeting, Orlando, 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^th 1xbet 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. INQOVI Product Monograph (1xbet 보너스 코드nada), July 2020.
13. 1xbet 보너스 코드QOVI Prescrib1xbet 보너스 코드g 1xbet 보너스 코드formation (Australia), January 2021.
14. De Kouchkovsky I and Abdul-Hay M. 'Acute myeloid leukemia: a compre1xbet 보너스 코드nsive review and 2016 update'. Blood 1xbet 보너스 코드ncer J. 2016;6(7):e441.