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Teva Pharma announces USFDA filing acceptance for Ajovy in Pediatric Episodic Migraine prevention

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-08-06T12:38:44+05:30  |  Updated On 6 Aug 2025 12:38 PM IST
Teva Pharma announces USFDA filing acceptance for Ajovy in Pediatric Episodic Migraine prevention
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Parsippany: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.

If approved, AJOVY would be the calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, helping to address the high unmet need for effective treatments for those living with migraine.

“Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “As we work to bring the benefits of AJOVY to younger patients, we build upon its proven success in adults. If approved, AJOVY could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population.”

The application was based on positive results from the Phase 3 SPACE trial, which evaluated the efficacy and safety of AJOVY for the prevention of episodic migraine in pediatric patients. The trial demonstrated statistically significant improvements in reducing monthly migraine days and monthly headache days compared to placebo, with a safety profile consistent with that observed in the adult population.

AJOVY was approved in the U.S. for the preventive treatment of migraines in adults in 2018. AJOVY is also approved in Europe and several other international markets, including Canada, Australia and Japan. As an anti-CGRP treatment, it targets the underlying causes of migraines and has demonstrated consistent efficacy in reducing the frequency and severity of attacks in adults.

SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12-week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.
AJOVY is indicated for preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
teva pharmaUSFDAajovyfremanezumab vfrmepisodic migraine
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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