Galcanezumab Shows Positive Long-Term Safety Results for Migraine Patients

Treatment with self-administered galcanezumab demonstrated a positive safety and tolerability profile in patients with migraine, according to Eli Lilly and Company.

Galcanezumab, a monoclonal antibody, was specifically designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which plays a role in migraine and cluster headaches. The investigational once-monthly, self-administered injection is under evaluation for the prevention of migraine and cluster headache, and returned positive results in Phase III studies.

“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,” Christi Shaw, president, Lilly Bio-Medicines, said. “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.”

Consistent with previous studies over a 12-month treatment period, the drug was 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. Detailed results from the 12-month, open label Phase III study will be presented at the 18th Congress of the International Headache Society (IHC) in Vancouver.

Notably, there was no clinical difference in the rate of adverse effects between the 120 mg and 240 mg dosage groups.

Lilly plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for galcanezumab in the second half of 2017 along with submissions to other regulatory agencies around the world.

The 12-month, randomized, open-label study evaluated the safety and effectiveness of 2 doses administered subcutaneously, 120 mg or 240 mg once monthly, following a 240-mg starting dose. The doses were administered in 270 patients with episodic and chronic migraine. Participating patients 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 the drug and additional safety measures.

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

The most commonly reported adverse effects in both groups included injection site pain, nasopharyngitis and upper respiratory tract infection. Serious effects were reported by 3 patients in the 120-mg dosing group and 7 patients in the 240-mg group.

In the study, 4.8% of patients discontinued treatment due to adverse effects. The incidence of both treatment-emergent effects and adverse effects leading to the discontinuation of the study were not statistically significantly different between the two groups. The company will submit its findings for publication in peer reviewed journals in the coming year.

In June, galcanezumab returned positive results in Phase III studies, representing a crucial step forward for patients without an effective therapy for symptoms. Aside from galcanezumab, 3 other investigative inhibitors fremanezumab, eptinezumab and AMG 334 (erenumab) are also considerable migraine prevention drugs.

Erenumab was backed by data from 4 Phase II and III trials displaying long-term efficacy in reduction of patient monthly migraine days. Erenumab is scheduled for a Prescription Drug User Fee Act (PDUFA) target action date May 17, 2018. Neurology is steps closer to releasing effective migraine prevention medication to its market.

A press release regarding the study results was made available.

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