CPT: Pharmacometrics & Systems Pharmacology (May 2023)

Population pharmacokinetic modeling and simulation of maribavir to support dose selection and regulatory approval in adolescents with posttransplant refractory cytomegalovirus

  • Kefeng Sun,
  • Siobhan Hayes,
  • Colm Farrell,
  • Ivy H. Song

DOI
https://doi.org/10.1002/psp4.12943
Journal volume & issue
Vol. 12, no. 5
pp. 719 – 723

Abstract

Read online

Abstract Maribavir was approved by the US Food and Drug Administration for the treatment of patients aged ≥12 years and weighing ≥35 kg with posttransplant cytomegalovirus infection/disease refractory (with/without resistance) to valganciclovir, ganciclovir, cidofovir, or foscarnet, with an oral dose of 400 mg twice daily. With no pediatric clinical data available and difficulty in trial recruitment, population pharmacokinetic modeling and simulations were conducted to predict the pharmacokinetics and inform maribavir dosing in adolescents.