Positive results from second Phase III HALO study of fremanezumab (TEV-48125), an investigational treatment for the prevention of episodic migraine.- Teva

Teva Pharmaceutical Industries Ltd.announced positive results from the second Phase III HALO study of fremanezumab (TEV-48125), an investigational treatment for the prevention of migraine. In the episodic migraine (EM) study, patients treated with monthly and quarterly fremanezumab experienced clinically and statistically significant improvements in all endpoints and 12 pre-specified analyses.

Participants in this trial had a mean of 9.1 migraine days per month and reported 39 days with functional impairment per quarter. In this severely affected population, Fremanezumab given monthly improved the average number of migraine days, relative to baseline, by 41.6% for the duration of the trial (-3.7 days vs. -2.2 days for placebo, p < 0.0001). Number of days with disability were decreased by 64.7% (p =0.0021) and medication consumption was decreased by 39.0%( p < 0.0001). The quarterly SC dose, which was uniquely tested in this program, also yielded highly significant results for decrease in migraine days (-3.4 days or 37.0%, p < 0.0001) and for all other comparisons. Also unique to this development, both dose regimens highly significantly improved migraine in subjects on stable doses of other prophylactic medications (-4.0 days for monthly dose vs -2.0 days for placebo, p = 0.001; -3.7 days for quarterly dose, p = 0.006).All other pre-specified analyses were met and were highly statistically significant. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.

Comment: Teva�s Phase III HALO program is now complete, encompassing more than 2000 patients, meeting all 25 primary and secondary analyses across both monthly and quarterly dosing regimens in episodic and chronic migraine studies.

Comment: Teva plans to submit a Biologics License Application to the FDA for fremanezumab later this year, 2017, in both episodic and chronic migraine with anticipated approval and launch in the second half of 2018.