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Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

219
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
219
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
165
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

231
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
231
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

214
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

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Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
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Updated: Jan 6, 2026

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Fremanezumab: Pediatric First Approval.

Hannah A Blair1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs
|September 29, 2025
PubMed
Summary
This summary is machine-generated.

Fremanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, is now approved for preventing episodic migraine in pediatric patients aged 6-17. This marks a significant milestone in migraine treatment for younger individuals.

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Area of Science:

  • Neurology
  • Pharmacology
  • Immunology

Background:

  • Migraine is a complex neurological disorder impacting millions globally.
  • Calcitonin gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology.
  • Existing treatments for pediatric migraine have limitations, necessitating novel therapeutic options.

Purpose of the Study:

  • To summarize the development of fremanezumab, a CGRP-targeting monoclonal antibody.
  • To highlight the milestones leading to the pediatric approval of fremanezumab for migraine prevention.
  • To provide an overview of fremanezumab's journey from development to its expanded indication.

Main Methods:

  • Review of clinical trial data and regulatory submissions for fremanezumab.
  • Analysis of fremanezumab's mechanism of action targeting CGRP.
  • Examination of the pharmacokinetic and pharmacodynamic profiles in pediatric populations.

Main Results:

  • Fremanezumab, a humanized monoclonal antibody, selectively targets CGRP.
  • The drug received US FDA approval for adult migraine prevention in 2018.
  • In August 2025, fremanezumab gained approval for episodic migraine prevention in pediatric patients (6-17 years, ≥45 kg).

Conclusions:

  • Fremanezumab represents a significant advancement in migraine management for pediatric patients.
  • The targeted inhibition of CGRP offers a novel therapeutic strategy for episodic migraine.
  • This pediatric approval expands treatment options for a vulnerable patient population.