Teva reports positive results for fremanezumab in phase IIIb migraine trial

Teva Pharmaceutical Industries Ltd. announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, 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.

“We are pleased to share the topline results of this study,” said Danny McBryan, M.D., Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. “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.”

Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication.

“With robust effect sizes for the primary endpoint, the FOCUS trial produced clinically meaningful results that demonstrated the effectiveness of fremanezumab in a population of patients that are difficult to treat and who require other treatment options,” said Matthias Mueller, M.D. MSc, Vice President Global Medical Affairs, Head of Therapeutic Areas and Scientific Communications at Teva. “We look forward to bringing forward additional insights from the study in the future.”