Population pharmacokinetics of selexipag for dose selection and confirmation in pediatric patients with pulmonary arterial hypertension

Selexipag is an oral selective prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension (PAH) in adults. To date, no treatment targeting the prostacyclin pathway is approved for pediatric patients. Our goal is to identify a pediatric dose regimen that results in co...

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Bibliographic Details
Published in:CPT: pharmacometrics and systems pharmacology 2024-12, Vol.13 (12), p.2185-2195
Main Authors: Axelsen, Lene Nygaard, Kümmel, Anne, Perez Ruixo, Juan Jose, Russu, Alberto
Format: Article
Language:English
Subjects:
Acetamides - administration & dosage
Acetamides - pharmacokinetics
Acetates - administration & dosage
Acetates - pharmacokinetics
Adolescent
Adults
Age
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - pharmacokinetics
Body Weight
Child
Child, Preschool
Dose-Response Relationship, Drug
Electrons
Female
Foreign exchange rates
Humans
Male
Models, Biological
Pediatrics
Pharmacokinetics
Pulmonary Arterial Hypertension - drug therapy
Pulmonary arteries
Pulmonary hypertension
Pyrazines - administration & dosage
Pyrazines - pharmacokinetics
Receptors, Epoprostenol - agonists
Smooth muscle
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Summary:Selexipag is an oral selective prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension (PAH) in adults. To date, no treatment targeting the prostacyclin pathway is approved for pediatric patients. Our goal is to identify a pediatric dose regimen that results in comparable exposures to selexipag and its active metabolite JNJ‐68006861 as those shown to be efficacious in adult PAH patients. Extrapolation from the population pharmacokinetic (PK) model developed in adults (GRIPHON study; NCT01106014) resulted in the definition of three different pediatric body weight groups (≥9 to
ISSN:2163-8306
2163-8306
DOI:10.1002/psp4.13231