Eli Lilly and Company announced that treatment with self-administered galcanezumab for up to 12 months demonstrated a positive safety and tolerability profile in patients with migraine, consistent with previous studies. Detailed results from a 12-month, open-label phase 3 study presented at the 18th Congress of the International Headache Society (IHC) in Vancouver.

Over the 12-month treatment period, galcanezumab was also associated with a statistically significant reduction in the number of monthly migraine headache days with both doses (5.6 days for 120 mg and 6.5 days for 240 mg, p < 0.001 for both dosing groups). Notably, there was no clinically meaningful difference in the rate of adverse events between galcanezumab 120 mg and 240 mg dosing groups.

"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 two 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."   

Lilly plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

Patients were randomized to treatment with galcanezumab 120 mg or galcanezumab 240 mg once-monthly for 12 months. The initial dose of galcanezumab was administered by a healthcare provider, with subsequent doses self-administered by the patient via prefilled syringe or auto-injector pen.

The most commonly reported adverse events (=10%) in both dosing groups included injection site pain, nasopharyngitis and upper respiratory tract infection. Serious adverse events were reported by three patients in the 120 mg dosing group and seven patients in the 240 mg group.

In this study, 4.8 per cent of patients discontinued treatment due to adverse events. The incidence of both treatment-emergent adverse events and adverse events leading to study discontinuation were not statistically significantly different between the two dosing groups.

Lilly will submit these findings for publication in a peer-reviewed journal in the coming year.

This 12-month, randomized, open-label study evaluated the safety and effectiveness of two doses of galcanezumab administered subcutaneously (120 mg or 240 mg once-monthly, following a 240 mg starting dose) in 270 patients with episodic and chronic migraine. Patients that participated in the trial had an average of 10.6 migraine headache days per month at baseline. The primary endpoints included the percentage of patients who discontinued treatment with galcanezumab and additional safety measures.

Galcanezumab is a monoclonal antibody specifically 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. Galcanezumab is an investigational once-monthly, self-administered injection under evaluation for the prevention of migraine and cluster headache.