Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has reported positive results from a Phase III HALO study of chronic migraine treatment fremanezumab. In the study, patients treated with fremanezumab experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo (-2.5 days) during the 12 week period after first dose, for both monthly and quarterly dosing regimens. Similar to the Phase II trials, patients that were on both monotherapy and stable doses of prophylactic medications were included in the trial.
The treatment became part of Teva's drug development portfolio in 2014 when it acquired Labrys Biologics for $825 million. Teva hopes to have FDA marketing approvals before the end of 2017.
Patients treated with fremanezumab also experienced significant improvement compared with placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
Teva Global R&D president and CSO Dr. Michael Hayden said, “Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life. Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine. We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”
Based on these results, Teva plans to submit a Biologics License Application to the US Food and Drug Administration (FDA) for fremanezumab later this year. Teva’s Phase III HALO study in Episodic Migraine (EM) will report topline results in the coming weeks.
Teva does not provide monetary estimates for products in development, but forecasts by the analysts for development of its drugs for migraines and severe headaches mention a market of $3 billion a year in which there is currently no dominant drug.