The US Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm) to prevent episodic migraine in paediatric patients.
The drug, which is already approved in the US to prevent migraine in adults, is now authorised for use in patients aged six to 17 years who weigh at least 45 kilograms.
One in ten children and adolescents in the US are affected by migraine, a neurological condition that can cause pain, nausea, vomiting and sensitivities to light and sound.
Preventative treatment can help reduce the frequency of migraine attacks, reducing the condition’s impact on daily functioning.
Given once a month either by a healthcare professional or at home by a patient or caregiver, Ajovy is a monoclonal antibody designed to block the Calcitonin Gene-related peptide (CGRP) protein, which is related to pain transmission in the brain.
It is hoped that the once-monthly dosing schedule will support adherence and reduce treatment burden for families.
Chris Fox, executive vice president, US commercial and innovative franchise lead and head of global marketing business at Teva, said: “Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood.
“With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”
The phase 3 SPACE study has been evaluating the efficacy and safety of Ajovy in over 230 paediatric patients with episodic migraine.
Data presented by Teva in December last year showed that, over three months, Ajovy significantly reduced both monthly migraine and headache days when compared to placebo.
A significantly higher number of children achieved a 50% response rate with Teva’s drug than with placebo, at 47.2% versus 27%, and benefits were similar across age subgroups and between boys and girls.
Also welcoming the authorisation, Jennifer McVige, paediatric neurologist at the DENT Neurologic Institute, said: “Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”