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Area of Science:

  • Pharmacology
  • Hepatology
  • Hematology

Background:

  • Thrombocytopenia is a common complication in patients with chronic liver disease (CLD), increasing bleeding risk during surgical procedures.
  • Avatrombopag is a small molecule thrombopoietin receptor agonist designed for oral administration.
  • Current treatment options for thrombocytopenia in CLD patients are limited, especially for those undergoing procedures.

Purpose of the Study:

  • To summarize the development milestones of avatrombopag.
  • To highlight the regulatory approval for treating thrombocytopenia in adult patients with CLD scheduled for a procedure.

Main Methods:

  • Review of clinical development data and regulatory submissions for avatrombopag.
  • Analysis of pharmacokinetic and pharmacodynamic properties of avatrombopag.
  • Evaluation of safety and efficacy in the target patient population.

Main Results:

  • Avatrombopag received its first global approval in the USA in May 2018 for thrombocytopenia in adult patients with CLD undergoing procedures.
  • A Marketing Authorization Application was submitted to the EMA in April 2018 for the same indication.
  • Ongoing clinical development for other thrombocytopenic disorders, including immune thrombocytopenic purpura and chemotherapy-induced thrombocytopenia.

Conclusions:

  • Avatrombopag represents a significant therapeutic advancement for managing thrombocytopenia in adult patients with CLD.
  • The approval facilitates improved procedural safety by addressing low platelet counts.
  • Further development is underway to expand avatrombopag's utility in other thrombocytopenic conditions.