Teva’s Ajovy turns into first migraine prevention drug authorised for kids
The US Meals and Drug Administration (FDA) has authorised a label growth to Teva’s Ajovy in sure youngsters and adolescents, making it the primary migraine prevention drug of its type within the age group.
Single-dose injectable Ajovy (fremanezumab-vfrm) is now authorised for the preventive therapy of episodic migraine in youngsters and adolescent sufferers aged between six and 17 years who weigh 45kg or extra.
Ajovy is a part of a category of medication known as calcitonin gene-related peptide (CGRP) inhibitors, which block a protein concerned in triggering migraines.
The FDA authorised Ajovy for adults in 2018. Israel-based Teva narrowly missed having the primary CGRP-targeting drug authorised for migraines on the time, following Novartis and Amgen’s Aimovig (erenumab) approval earlier within the 12 months. Nonetheless, the remedy isn’t authorised for kids or adolescents, that means its affected person attain is not as extensive as Ajovy.
One in ten youngsters and adolescents within the US suffers from migraines, one of the frequent neurological situations. Paediatric migraine is commonly underrecognised and undertreated, disrupting life-style resembling faculty attendance and social interactions. Episodic migraine refers to recurring extreme complications in youngsters that don’t happen every day however are frequent sufficient to intervene with every day actions.
Ajovy is run as soon as a month and accessible for in-office or at-home use, providing an accessible therapy possibility for sufferers and their caregivers, resembling dad and mom. The next-dose model, given each three months as three injections, can also be accessible for adults.
Teva’s Section III SPACE trial (NCT03539393) with the drug demonstrated statistically important superior efficacy in comparison with placebo over three months within the paediatric inhabitants. The protection profile was according to that within the grownup inhabitants – the commonest unwanted effects being itchiness, rash and drug hypersensitivity.
Teva’s world advertising and marketing enterprise head Chris Fox stated: “Migraines are a typical but invisible situation that may severely disrupt every day life for kids and adolescents, usually leaving them neglected and misunderstood.
“With this FDA approval, Ajovy now gives youthful sufferers a brand new therapy possibility, addressing a long-standing hole in care and providing households added assist as they navigate the challenges of this situation.”
The label growth in youngsters and adolescents offers Teva an edge over Novartis/Amgen, in addition to Eli Lilly, whose Emgality (galcanezumab) – additionally a CGRP inhibitor – can also be authorised and in the marketplace.
Final 12 months, Teva’s migraine therapy Ajovy generated $507m in world gross sales, an 18% improve in comparison with the earlier 12 months. Evaluation by GlobalData forecasts gross sales of $885m by 2031.
Neither Amgen nor Lilly disclosed particular gross sales for his or her two merchandise in 2024.
GlobalData is the dad or mum firm of Pharmaceutical Know-how.
Join our every day information round-up!
Give your enterprise an edge with our main business insights.
