Teva announced results from the Phase 3 HALO study of fremanezumab, a novel treatment being investigated for the prevention of migraine.

The HALO Clinical Research Program consists of two 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that compared fremanezumab to placebo in adults with episodic and chronic migraine. 

Results from the chronic migraine study showed that compared to placebo, patients treated with fremanezumab had a statistically significant reduction in the number of monthly headache days of at least moderate severity during the 12 weeks after the initial dose, for both monthly and quarterly dosing regimens (–4.6 days and –4.3 days, respectively vs. –2.5 days for placebo).

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In addition, both monthly and quarterly dosing regimens were associated with significant improvements in all secondary endpoints (response rate, onset of efficacy, efficacy as monotherapy, disability). Injection site pain was the most common adverse event reported in both the active and placebo groups.

Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP ligand. Teva plans to submit a Biologics License Application (BLA) for fremanezumab to the Food and Drug Administration later this year. Topline results from the episodic migraine study will be reported in the coming weeks.

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