Phase III HALO study of TEV 48125 in episodic migraine published in Journal of the American Medical Association.- Teva Pharma.
Teva Pharmaceutical announced the publication of data from the Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly (every three months) and monthly subcutaneous dosing regimens of TEV 48125 (fremanezumab) for the prevention of episodic migraine (EM). These pivotal data were published online by The Journal of the American Medical Association (JAMA).
The study evaluated the use of both quarterly and monthly dosing regimens of subcutaneous fremanezumab, compared with placebo in patients with EM (defined as 14 migraine headache days or less per month) who had previously failed multiple medication classes. The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens. The baseline mean number of monthly migraine days was 8.9, 9.2, and 9.1 days in the monthly dosing, quarterly dosing, and placebo groups, respectively. During the 12-week period after the first dose, fremanezumab treatment significantly reduced monthly migraine days to 4.6 days for monthly and 4.9 days for quarterly dosing compared with 5.9 days for placebo. Response rates of at least 50% reduction in monthly average number of migraine days were also significantly greater in monthly (47.7%) and quarterly (44.4%) dosing compared with placebo (27.9%).
Additionally, the baseline mean number of monthly days of any acute headache medication use was 7.7, 7.9, and 7.7 days in the monthly, quarterly, and placebo groups, respectively. Fremanezumab significantly reduced monthly days of any acute headache medication use to 4.5 days for monthly and 4.6 days for quarterly dosing compared with 5.4 days for placebo. The most common adverse events in patients treated with fremanezumab were injection site pain, induration, and erythema.
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