Phase III study of self-administered galcanezumab shows significant reduction in monthly migraine headache days.- Eli Lilly

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 III study will be 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.

Study Results- 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 percent 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.