Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today 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 only 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.
About SPACE
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.
About AJOVY
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.
About Migraine
Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.
