Teva Pharmaceutical has reported positive data from two Phase II/III clinical trials of Ajovy (fremanezumab) conducted to treat migraine patients in Japan.
Ajovy is an anti-calcitonin gene-related peptide (CGRP) drug indicated in the US and EU for the preventive treatment of migraine.
In Japan, the drug is being developed by Otsuka Pharmaceutical, which signed an exclusive licence agreement in May 2017 for development and sales in the country.
Data from the Phase II/III trials in Japan showed that the primary goals were met, demonstrating clinical and statistical significance in patients with chronic migraine and episodic migraine, respectively, on Ajovy compared to placebo.
The drug also led to statistically significant improvements on all secondary endpoints. It was well-tolerated with an adverse events profile similar to that of placebo.
Results from these pivotal studies will enable the submission of an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking marketing authorisation.
Teva Pharmaceutical Migraine & Headache global medical lead Joshua Cohen said: “This study adds to the wealth of positive AJOVY data we have in patients globally.
“The annual prevalence of migraine in Japan is 8.4% of adults, so we are pleased to be one step closer to bringing AJOVY to patients in Japan who could benefit from a preventive treatment.”
Last July, Teva reported positive findings from the exploratory endpoint analysis of the Phase IIIb FOCUS study that assessed fremanezumab as a preventive therapy for migraine in adults.
A clinically meaningful decrease was observed in the monthly average migraine days, with ≥50% response rates sustained over three months and significantly greater in subjects treated with fremanezumab.