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Teva Confirms AJOVY® (fremanezumab) Effectiveness and Safety in Preventing Migraines with Phase 3 Trial Results in China

Friday, April 12, 2024

Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), has released findings from a Phase 3 trial examining the effectiveness and safety of AJOVY in preventing migraines in adult Chinese patients.

The trial showed that AJOVY met its primary goal and all secondary objectives, significantly reducing the frequency of migraine days per month compared to a placebo. It also demonstrated early efficacy within the first month, a notable responder rate indicating a 50% reduction in migraine days, and reduced usage of acute headache medication over a three-month period following initial use. Importantly, AJOVY was well tolerated with no safety concerns, consistent with previous Phase 3 data from the U.S. and EU where AJOVY was approved for preventing migraines in adults.

Migraine affects a significant portion of the Chinese population, with an estimated 14.3% of non-elderly adults affected. However, only a small fraction receive proper diagnosis and treatment. Dr. Eric Hughes, Teva's Executive Vice President of Global R&D and Chief Medical Officer, emphasized the importance of addressing this unmet need globally, particularly in regions like China with a substantial migraine population.

Migraine episodes can cause debilitating symptoms, impacting daily life and leading to anxiety and depression. AJOVY, a humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP), offers a promising preventive treatment option.

The Phase 3 double-blind study in China involved 365 adult participants randomized to receive AJOVY subcutaneously at either 225mg once-monthly for three months, a single dose of 675mg once-quarterly, or placebo. Dr. Shengyuan Yu, Director and Professor at the Department of Neurology, Chinese PLA General Hospital, highlighted the potential of AJOVY to improve the quality of life for migraine patients in China based on these promising results.

The study confirmed AJOVY's safety profile, with injection site reactions being the most common treatment-related adverse events.

The Phase 3 trial in China is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of AJOVY in patients aged 18-70 years with episodic or chronic migraine. The study aims to demonstrate AJOVY's efficacy and assess its safety when administered subcutaneously either monthly or quarterly.

AJOVY, available as a 225 mg/1.5 mL single dose injection, offers two dosing options: once monthly or once quarterly, administered either by healthcare professionals or at home by patients or caregivers.

 

Source: tevapharm.com

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