Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) of LY 2951742 (galcanezumab) show decrease in number of migraine attacks - Eli Lilly
Eli Lilly announced positive results from three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) of LY 2951742 (galcanezumab), for the prevention of episodic and chronic migraine, including late-breaking data on several key secondary endpoints for galcanezumab compared to placebo at both studied doses. In EVOLVE-1 and 2, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo, with statistically significant improvements observed at each month starting at one month of treatment. >A statistically significantly greater percentage of patients treated with both doses of galcanezumab achieved at least a 50 percent, 75 percent and 100 percent reduction in the number of migraine headache days compared to placebo over the six-month treatment period, in both studies after multiplicity adjustment.
In the REGAIN trial, over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo. Statistically significant improvements for both doses of galcanezumab were observed at each month starting at one month of treatment. A statistically significantly greater percentage of patients also achieved at least a 50 percent reduction in the number of migraine headache days compared to placebo over the three-month treatment period (27.6% for 120 mg and 27.5% for 240 mg compared to 15.4% for placebo, p<0.001 for both dosing groups after multiplicity adjustment.>
Compared with placebo over the three-month treatment period, a statistically significantly higher percentage of patients treated with the 240 mg dose of galcanezumab achieved at least a 75 percent reduction in the number of migraine headache days (8.8% compared to 4.5% for placebo, p<0.001) after multiplicity adjustment. detailed results from these studies will be presented at the american headache society ahs annual scientific meeting.>
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.