Teva announces FDA filling acceptance for Ajovy (fremanezumab) in pediatric episodic migraine prevention

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the 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 kg 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.

The application was based on positive results from the Phase III 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 (see most recent citation).  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.

“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, 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.