EVOLVE-1 and EVOLVE-2 are both randomized, double-blind, placebo-controlled global trials evaluating two doses of galcanezumab (240mg initial dose, then 120mg or 240mg once-monthly) vs. placebo for 6 months in patients with episodic migraine. Patients were included in the study if they experienced between 4-14 migraine headache days per month. The primary endpoint was the mean change from baseline in monthly migraine headache days over 6 months of treatment.
Both EVOLVE studies met their primary endpoint, showing that patients treated with either doses of galcanezumab experienced a significantly greater decrease in the average number of monthly migraine headache days, over the six-month treatment period, compared to placebo. In EVOLVE-1, patients treated with galcanezumab 120mg and 240mg had an average reduction of 4.7 days and 4.6 days, respectively, compared to 2.8 days in placebo-treated patients (P<0.001 for both doses). Results from EVOLVE-2 showed that the 120mg and the 240mg doses had an average reduction of 4.3 days and 4.2 days, respectively, vs. 2.3 days for placebo (P<0.001 for both doses).
The third study, REGAIN, is a randomized, double-blind, placebo-controlled global trial evaluating galcanezumab 120mg and 240mg for 3 months in patients with chronic migraine. Patients who experienced at least 15 headache days per month, of which at least eight met criteria for migraine, were eligible for inclusion. The primary endpoint was the mean change from baseline in monthly migraine headache days over the 3-month treatment period.
REGAIN also met its primary endpoint, showing that patients treated with galcanezumab 120mg or 240mg experienced a significantly greater decrease in the average number of monthly migraine headache days vs. placebo-treated patients. The average reduction was 4.8 days for the 120mg and 4.6 days for the 240mg, compared to 2.7 days for placebo (P<0.001 for both doses).
In all three studies, treatment with either doses of galcanezumab was also associated with statistically significant improvement on the pre-specified secondary endpoints of response rates and measures of daily activities. The most commonly-reported adverse events in EVOLVE-1, EVOLVE-2, and REGAIN were injection site reactions, including pain.
Detailed study data will be presented at future scientific meetings this year and will be submitted to peer-reviewed journals. Based on these results, Lilly intends to submit a Biologics License Application (BLA) for galcanezumab to the Food and Drug Administration (FDA) in the second half of 2017.
Galcanezumab, an investigational monoclonal antibody designed to specifically inhibit calcitonin gene-related peptide (CGRP), is a once-monthly, self-administered subcutaneous injection.
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