Teva Reveals Phase 3 Trial Results for AJOVY® in Preventing Children's Episodic Migraine

Teva Pharmaceutical Industries Ltd. has announced promising results from its Phase 3 SPACE study, which evaluated the use of AJOVY (fremanezumab) in preventing episodic migraine among children and adolescents aged 6 to 17 years. The trial successfully met its primary endpoint, demonstrating that AJOVY showed a significantly higher efficacy over a 12-week treatment period compared to a placebo. Importantly, the safety profile of the medication was consistent with that observed in adult patients, with no new safety concerns emerging. Full results from the study are expected to be presented at a medical conference later this year.

Eric A. Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva Pharmaceuticals, highlighted the significance of the study’s outcome, especially given the lack of effective preventive therapies for young migraine sufferers. He emphasized that the SPACE study’s findings support Teva’s efforts to extend the benefits of AJOVY to pediatric patients, who currently have limited treatment options. Hughes expressed his satisfaction with the efficacy and safety of AJOVY in various migraine population groups, including children.

The SPACE study’s results are particularly noteworthy as they provide the first Phase 3 evidence supporting the safety and efficacy of an anti-CGRP monoclonal antibody for treating migraines in a pediatric demographic. This is a critical development given the current scarcity of approved preventive treatments for migraines in children and adolescents, a group significantly affected by this debilitating condition. Teva is continuing its research into the effects of AJOVY on pediatric patients suffering from chronic migraine.

Migraine is a common condition among children, affecting an estimated 7.7% of this population. The prevalence of migraines increases with age, rising from 5% among children aged 5 to 10 years to about 15% in adolescents. The impact of migraines on young individuals is substantial, often leading to missed school days, diminished academic performance, and reduced participation in social activities.

The SPACE study was a multicenter, randomized, double-blind, placebo-controlled trial involving 235 pediatric patients aged 6 to 17 years. The study aimed to compare the efficacy, safety, and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12-week period for the preventive treatment of episodic migraine.

AJOVY is currently approved for the prophylaxis of migraine in adults who experience at least four migraine days per month. The medication is available as a 225 mg/1.5 mL single-dose injection, either in a pre-filled syringe or, in some countries, a pre-filled pen. There are two dosing options: a 225 mg dose administered monthly as a subcutaneous injection, or a 675 mg dose administered quarterly as three subcutaneous injections. AJOVY can be administered by a healthcare professional or at home by the patient or a caregiver, with no need for a starting dose to initiate treatment.

Teva Pharmaceutical Industries Ltd. is a global leader in the pharmaceutical industry, leveraging its expertise in generics and commitment to innovation. With over 120 years of history, Teva’s global network spans 58 markets and employs around 37,000 people. The company is dedicated to advancing scientific innovation and delivering high-quality medicines to improve health outcomes for millions of patients worldwide.