An experimental therapy being developed by Amgen and Novartis to prevent chronic migraine has hit its primary targets, confirming safety and efficacy in patients over the 12-week treatment period.
The Phase II study assessed the monoclonal antibody AMG 334 (erenumab) at two doses, 70mg and 140mg, administered subcutaneously once a month; both doses met the primary endpoint of a statistically significant reduction in the number of monthly migraine days versus placebo.
Overall, patients had a mean baseline of 18 migraine days per month. Those randomised to the 70mg and 140mg dose groups experienced a mean 6.6-day reduction from baseline in monthly migraine days in both groups, versus 4.2 days in the placebo group.
The drug's safety and tolerability profile was similar to placebo in both treatment groups, and No adverse event was reported in greater than five percent of patients treated with AMG 334; the most commonly reported adverse events included injection site pain, infection of the upper respiratory tract and nausea.
Migraine is a leading cause of disability, affecting more than 10% of people worldwide - within the overall migraine population, people with chronic migraine experience the greatest impact on daily activities and quality of life.