The US Food and Drug Administration have green-lighted use of Eli Lilly’s non-opioid pain drug Emgality for the prevention of migraine.
The drug is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which is believed to play a role in migraine and cluster headache.
Data from three Phase III studies - EVOLVE-1, EVOLVE-2 and REGAIN – involving 2,901 patients, showed that patients treated with Emgality (galcanezumab) experienced a statistically significantly greater drop in the average number of monthly migraine headache days compared to placebo.
Across the trials, the drug typically reduced the number of ‘migraine days’ by four to five per month, compared to a reduction of between two and three days with placebo.
Migraine affects more than 30 million adults in the US. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the country is estimated to be $56 billion annually, yet the condition remains under-recognised and under-treated, Lilly says.
"Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment," stressed Christi Shaw, president, Lilly Bio-Medicines. "With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease."
Earlier this month Emgality was also put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, specifically for migraine prophylaxis in adults who have at least four migraine days per month.