The Phase 3b FOCUS study that evaluated the safety and efficacy of fremanezumab (Ajovy) for preventive treatment of migraine in adult patients has yielded positive results, announced Teva Pharmaceutical Industries. The trial was conducted on patients who previously experienced inadequate responses to 2-4 classes of preventive medications.
Ajovy, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.
The study enrolled 838 patients who experienced chronic or episodic migraines and had inadequate responses (defined as lack of efficacy after at least 3 months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient) to other classes of drugs (ie, beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, valproic acid). Patients were randomized 1:1:1 into a quarterly or monthly dosing regimen of fremanezumab, or placebo for 12 weeks.
- Over the 12 week period, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo (-0.6 days) over the 12 week assessment period, for both monthly (-4.1 days, p<0.0001) and quarterly (-3.7 days, p<0.0001) dosing regimens.
- In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens.
- There were no safety signals detected in the study.
“This study design is distinct in that it is the largest trial to date in patients who failed to respond to multiple classes of preventive migraine treatments, and is the first study of its type to be conducted in chronic, as well as episodic, migraine patients,” said Danny McBryan, MD, Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva.
Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication.