US regulators have accepted for review Eli Lilly’s investigational non-opioid pain drug galcanezumab for the prevention of migraine.
The drug - 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 - has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.
The move rides on the back data from three Phase III studies - EVOLVE-1, EVOLVE-2 and REGAIN – involving 2,901 patients, in which those treated with galcanezumab experienced a statistically significantly greater drop in the average number of monthly migraine headache days compared to placebo.
Across the trials, galcanezumab 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 is more than a headache. It is a debilitating disease affecting one in eight Americans and may cause days of lost productivity each month," said Christi Shaw, president of Lilly Bio-Medicines.
"We have worked for more than 25 years to develop innovative migraine therapies, and we are truly pleased to be one step closer to potentially providing a new self-administered and effective preventive treatment option that may help people experience fewer migraine days."