An experimental humanized monoclonal antibody was found to reduce migraine headache days by nearly 50%.
Eli Lilly recently announced that self-administered galcanezumab significantly reduced the number of migraine headache days. A 12-month, phase 3 trial also showed that the humanized monoclonal antibody demonstrated a positive safety and tolerability profile, according to a press release.
Migraine is a neurological condition characterized by severe headaches that can cause nausea, vomiting, sensitivity to light and sound, and vision disruption. More than 36 million Americans experience migraine headaches, but the condition remains under-treated, according to the release.
Galcanezumab is a monoclonal antibody designed to inhibit the activity of calcitonin gene-related peptide, which is thought to be involved with migraine and cluster headaches.
Included in the study were 270 patients with episodic and chronic migraine who were randomized to receive 2 doses of subcutaneous galcanezumab 120-mg or 240-mg once per month, following a 240-mg initial dose. At baseline, patients experienced an average of 10.6 migraine headache days per month.
The primary endpoint was the number of patients who discontinued treatment and other safety measures, according to Lilly.
The investigators found that treatment with galcanezumab was linked to a significant reduction in monthly migraine days for both doses of the drug. In the 120-mg group, patients experienced an average of 5.6 days per month, while patients in the 240-mg group experienced an average of 6.5 days, according to the release.
The most common adverse events in both groups included injection site pain, nasopharyngitis, and upper respiratory tract infection. Lilly reports that there were no clinically meaningful differences in adverse events between the dosing groups.
Fewer than 5% of patients discontinued treatment due to adverse events. The prevalence of treatment-emergent adverse events and those leading to discontinuation were not statistically significant between treatment cohorts, according to Lilly.
Lilly plans to submit a biologics license application to the FDA in 2017, in addition to submissions to other regulatory agencies, according to the release.
"These long-term results are significant for the millions of Americans with migraine. They reinforce the efficacy and safety profile of galcanezumab while supporting its potential use as a self-administered, monthly injection," said Christi Shaw, president of Lilly Bio-Medicines. "After more than 2 decades of research, Lilly is excited to submit galcanezumab to the FDA as a new potential treatment option that can provide more migraine-free days for people suffering with migraine."