Teva announced topline results from a Phase 3b study evaluating the efficacy and safety of fremanezumab (Ajovy) in adult patients with migraine who previously experienced inadequate responses to 2-4 classes of preventive medications.
The FOCUS study enrolled a total of 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.
“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.
Results showed that over the 12 week period, the fremanezumab groups experienced a significant reduction in the average number of migraine days compared with placebo (-4.1 days [P<.0001] and -3.7 days [P<.0001] for monthly and quarterly dosing regimens, respectively vs -0.6 days for placebo).
Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication.
For more information visit TevaPharma.com.