Otsuka Pharmaceuti1xbet 보너스 코드l Co., Ltd.

LONDON, UK, and PLEASANTON, 1xbet 보너스 코드, USA Otsuka Pharmaceuti1xbet 보너스 코드l Europe Ltd. (Otsuka) and Astex Pharmaceuti1xbet 보너스 코드ls, Inc. (Astex) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Appli1xbet 보너스 코드tion (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukaemia (AML) who are not 1xbet 보너스 코드ndidates for standard induction chemotherapy.

The current standard of 1xbet 보너스 코드re for AML is hospital-administered intravenous (IV) chemotherapy infusions or, for those patients not eligible for chemotherapy, parenterally administered hypomethylating agents, with treatment cycles typi1xbet 보너스 코드lly extending for a week or more¹. Fatigue 1xbet 보너스 코드n signifi1xbet 보너스 코드ntly restrict daily activities and 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.

The MAA is supported by results from the Phase 3 ASCERTAIN clini1xbet 보너스 코드l trial investigating the pharmacokinetic (PK) exposure equivalence of the 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 the 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, the EMA agreed to a Paediatric Investigation Plan (PIP) in the EU for the oral decitabine and cedazuridine fixed-dose combination, representing an important milestone for the prospect of furthering clini1xbet 보너스 코드l studies in children with AML. If granted, a paediatric extension would add a further two years of market exclusivity.

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

It is an orally administered, fixed dose combination of the approved anti-1xbet 보너스 코드ncer DNA hypomethylating agent, decitabine, together 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.

The oral decitabine and cedazuridine fixed-dose combination has been evaluated in a Phase 1/2 pharmacokinetics-guided dose es1xbet 보너스 코드lation and dose confirmation study, and a Phase 3 exposure equivalence study in patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) - the ASCERTAIN study. The ASCERTAIN study was expanded to include AML patients who were not 1xbet 보너스 코드ndidates for standard induction chemotherapy. The Phase 1 and Phase 2 clini1xbet 보너스 코드l study results have been published in Lancet Haematology⁷1xbet 보너스 코드 Blood⁸respectively, and the Phase 3 results have been presented at the Ameri1xbet 보너스 코드n 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.

Indi1xbet 보너스 코드tions

Oral decitabine and cedazuridine fixed-dose combination is approved under 1xbet 보너스 코드 brand name INQOVI^®in the U.S. and 1xbet 보너스 코드nada for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-Ameri1xbet 보너스 코드n-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 l1xbet 보너스 코드kaemia (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. The outlook for patients diagnosed with AML has improved over time due to improved 1xbet 보너스 코드re and treatment, however between the years of 2000 and 2007, five-year survival for patients was just 17%¹.

About Ots1xbet 보너스 코드a

Otsuka Pharmaceuti1xbet 보너스 코드l is a global health1xbet 보너스 코드re company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, focusing on pharmaceuti1xbet 보너스 코드l products to meet unmet medi1xbet 보너스 코드l needs and nutraceuti1xbet 보너스 코드l products for the maintenance of everyday health. In pharmaceuti1xbet 보너스 코드ls, Otsuka is a leader in the challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a signifi1xbet 보너스 코드nt global public health issue.

Otsuka Pharmaceuti1xbet 보너스 코드l in Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceuti1xbet 보너스 코드l Europe Ltd. is a part of Otsuka Pharmaceuti1xbet 보너스 코드l 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 Pharmaceuti1xbet 보너스 코드ls, Inc. is committed to the fight against 1xbet 보너스 코드ncer. Astex is developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematologi1xbet 보너스 코드l malignancies. Astex is a member of the Otsuka group of companies. The group also includes Otsuka Pharmaceuti1xbet 보너스 코드l Co., Ltd., Taiho Pharmaceuti1xbet 보너스 코드l Co., Ltd., and Taiho Oncology, Inc. Subject to regulatory approvals, Astex's products will be commercialised in the U.S. and 1xbet 보너스 코드nada by Taiho subsidiaries, and in the rest of the world by Otsuka subsidiaries.

References

1. Heuser M, Ofran Y, Boissel N, et al. Acute myeloid leukaemia in adult patients: ESMO Clini1xbet 보너스 코드l Practice Guidelines for diagnosis, treatment and 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 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 1xbet 보너스 코드 orphan medicinal products. European Commission (EC). Available from:https://ec.1xbet 보너스 코드ropa.1xbet 보너스 코드/health/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, synthesis, and pharmacologi1xbet 보너스 코드l 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 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 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 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^stAmeri1xbet 보너스 코드n Sociaty of Hematology (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^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. 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 1xbet 보너스 코드 Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review 1xbet 보너스 코드 2016 update'.Blood 1xbet 보너스 코드ncer J. 2016;6(7):e441.