A new drug is showing promise in clinical trials for the reduction of chronic migraine headaches. Erenumab – a human monoclonal antibody developed by Amgen and Novartis – showed a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine.
“Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
The study included 667 patients (mean age 42.1, 79.0 percent female) who were randomized to receive either subcutaneous placebo (n=286) or subcutaneous erenumab 70 mg (n=191) or 140 mg (n=190) once a month.
Study participants had a mean baseline of 18.0 migraine days per month and a mean baseline of 21.1 headache days per month. Participants randomized to both erenumab dose groups experienced a statistically significant 6.6-day reduction from baseline in mean monthly migraine days compared with 4.2 days observed in the placebo group (p<0.001).
A reduction of 50 percent or more in number of monthly migraine days was observed in 40 percent and 41 percent (70 mg and 140 mg doses, respectively) of individuals in the erenumab groups at week 12, representing a significantly higher likelihood of response compared to 24 percent of those receiving placebo (both p<0.001). Reductions in monthly acute migraine-specific medication days were 3.5 days and 4.1 days in the 70 mg and 140 mg groups, respectively, representing significant improvements from baseline compared to a 1.6-day reduction in those receiving placebo (both doses p<0.001 versus baseline).
“As a neurologist, these findings are exciting because they demonstrate that erenumab could serve as an important new therapy option for reducing the burden of this often-disabling disease,” said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth.
Dr. Harper added, “The results from this global chronic migraine study are exciting because they support the efficacy of erenumab for a patient population that has had few therapeutic options. We look forward to advancing erenumab to help provide a potential new treatment option for patients with this debilitating disease.”
Erenumab is a fully human monoclonal antibody specifically designed for the prevention of migraine. It targets and blocks the Calcitonin-Gene-Related-Peptide (CGRP) receptor, which is thought to be pivotal in the genesis of migraine.
Data from the clinical trial was presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland.