Literature DB >> 29995177

Avatrombopag: First Global Approval.

Matt Shirley1.   

Abstract

Avatrombopag (Doptelet®) is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders. In May 2018 avatrombopag received its first global approval, in the USA, for use in the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. A Marketing Authorization Application for use of avatrombopag in this indication was submitted to the EMA in April 2018. Clinical development of avatrombopag in the treatment of other thrombocytopenic disorders, including immune thrombocytopenic purpura and chemotherapy-induced thrombocytopenia, is ongoing. This article summarizes the milestones in the development of avatrombopag leading to this first approval for the treatment of thrombocytopenia in adult patients with CLD.

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Year:  2018        PMID： 29995177     DOI： 10.1007/s40265-018-0949-8

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  9 in total

Review 1.  Thrombopoietin-receptor agonists.

Authors:  Paul A Basciano; James B Bussel
Journal:  Curr Opin Hematol       Date:  2012-09       Impact factor: 3.284

2.  A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia.

Authors:  James B Bussel; David J Kuter; Louis M Aledort; Craig M Kessler; Adam Cuker; Kelly B Pendergrass; Shande Tang; Joe McIntosh
Journal:  Blood       Date:  2014-05-06       Impact factor: 22.113

3.  Pharmacokinetics, Pharmacodynamics, Pharmacogenomics, Safety, and Tolerability of Avatrombopag in Healthy Japanese and White Subjects.

Authors:  Maiko Nomoto; Gina Pastino; Bhaskar Rege; Jagadeesh Aluri; Jim Ferry; David Han
Journal:  Clin Pharmacol Drug Dev       Date:  2017-03-24

4.  Phase II study of avatrombopag in thrombocytopenic patients with cirrhosis undergoing an elective procedure.

Authors:  Norah A Terrault; Tarek Hassanein; Charles D Howell; Shobha Joshi; John Lake; Linda Sher; Hugo Vargas; Joe McIntosh; Shande Tang; Tim M Jenkins
Journal:  J Hepatol       Date:  2014-07-15       Impact factor: 25.083

Review 5.  The biology of thrombopoietin and thrombopoietin receptor agonists.

Authors:  David J Kuter
Journal:  Int J Hematol       Date:  2013-07-03       Impact factor: 2.490

6.  Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia.

Authors:  Nezam H Afdhal; Edoardo G Giannini; Ghias Tayyab; Aftab Mohsin; Jin-Woo Lee; Angelo Andriulli; Lennox Jeffers; John McHutchison; Pei-Jer Chen; Kwang-Hyub Han; Fiona Campbell; Denise Hyde; Andres Brainsky; Dickens Theodore
Journal:  N Engl J Med       Date:  2012-08-23       Impact factor: 91.245

7.  Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia.

Authors:  Norah Terrault; Yi-Cheng Chen; Namiki Izumi; Zeid Kayali; Paul Mitrut; Won Young Tak; Lee F Allen; Tarek Hassanein
Journal:  Gastroenterology       Date:  2018-05-17       Impact factor: 22.682

8.  Pharmacokinetic/pharmacodynamic drug-drug interactions of avatrombopag when coadministered with dual or selective CYP2C9 and CYP3A interacting drugs.

Authors:  Maiko Nomoto; Cynthia A Zamora; Edgar Schuck; Peter Boyd; Min-Kun Chang; Jagadeesh Aluri; Y Amy Siu; W George Lai; Sanae Yasuda; Jim Ferry; Bhaskar Rege
Journal:  Br J Clin Pharmacol       Date:  2018-02-20       Impact factor: 4.335

Review 9.  The Use of Thrombopoietin Receptor Agonists for Correction of Thrombocytopenia prior to Elective Procedures in Chronic Liver Diseases: Review of Current Evidence.

Authors:  Kamran Qureshi; Shyam Patel; Andrew Meillier
Journal:  Int J Hepatol       Date:  2016-10-09
  9 in total
  10 in total

1.  Avatrombopag ethnic sensitivity analysis in chronic liver disease and thrombocytopenia patients: individual-level pooled analysis.

Authors:  Jun Lu; Brian D Jamieson; Ai-Min Hui
Journal:  Therap Adv Gastroenterol       Date:  2022-06-30       Impact factor: 4.802

2.  Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Authors:  Chunlu Li; Xiaoxuan Li; Feihong Huang; Jing Yang; Anguo Wu; Long Wang; Dalian Qin; Wenjun Zou; Jianming Wu
Journal:  Front Pharmacol       Date:  2019-07-26       Impact factor: 5.810

Review 3.  Current Advance in Thrombopoietin Receptor Agonists in the Management of Thrombocytopenia Associated With Chronic Liver Disease: Focus on Avatrombopag.

Authors:  Jemal Abdela
Journal:  Clin Med Insights Blood Disord       Date:  2019-10-21

4.  Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance.

Authors:  Ritsue Sasaki; Chikako Shiino; Michio Imawari; Roy Bentley; Bin Cai; Manami Yoshida; Nezam Afdhal
Journal:  Hepatol Res       Date:  2019-07-22       Impact factor: 4.288

5.  Avatrombopag Effectively Maintained Platelet Counts in a Patient with Immune Thrombocytopenia Who Was Intolerant to Tyrosine Kinase Inhibitor Therapy.

Authors:  Hillary S Maitland
Journal:  Am J Case Rep       Date:  2021-12-04

6.  Case Report: Successful Avatrombopag Treatment for Two Cases of Anti-PD-1 Antibody-Induced Acquired Amegakaryocytic Thrombocytopenia.

Authors:  Xiaofang Tu; Ali Xue; Suye Wu; Mengmeng Jin; Pu Zhao; Hao Zhang
Journal:  Front Pharmacol       Date:  2022-01-27       Impact factor: 5.810

Review 7.  Repurposing Pharmaceuticals Previously Approved by Regulatory Agencies to Medically Counter Injuries Arising Either Early or Late Following Radiation Exposure.

Authors:  Vijay K Singh; Thomas M Seed
Journal:  Front Pharmacol       Date:  2021-05-10       Impact factor: 5.810

Review 8.  Avatrombopag for the treatment of immune thrombocytopenia and thrombocytopenia of chronic liver disease.

Authors:  Abraham Z Cheloff; Hanny Al-Samkari
Journal:  J Blood Med       Date:  2019-09-05

9.  Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.

Authors:  Gerald A Soff; Yimei Miao; Gemma Bendheim; Jeanette Batista; Jodi V Mones; Rekha Parameswaran; Cy R Wilkins; Sean M Devlin; Ghassan K Abou-Alfa; Andrea Cercek; Nancy E Kemeny; Debra M Sarasohn; Simon Mantha
Journal:  J Clin Oncol       Date:  2019-09-23       Impact factor: 44.544

10.  Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies.

Authors:  Fred Poordad; Norah A Terrault; Naim Alkhouri; Wei Tian; Lee F Allen; Mordechai Rabinovitz
Journal:  Int J Hepatol       Date:  2020-01-25
  10 in total

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