Lilly reports positive data from Emgality’s Phase III migraine trials

8th May 2019 (Last Updated May 8th, 2019 00:00)

Eli Lilly has announced positive results from the Phase III EVOLVE-1 and EVOLVE-2 clinical trials that assessed Emgality (galcanezumab-gnlm) for the treatment of episodic migraine.

Lilly reports positive data from Emgality’s Phase III migraine trials
Teva discontinues cluster headache programme following futility analysis. Credit: Gerd Altmann from Pixabay.

Eli Lilly has announced positive results from the Phase III EVOLVE-1 and EVOLVE-2 clinical trials that assessed Emgality (galcanezumab-gnlm) for the treatment of episodic migraine.

Pooled subgroup analyses of efficacy data from the trials revealed a decrease in monthly migraine headache days in patients who were given Emgality, compared to those in placebo group.

In the analyses, patients were categorised into subgroups of low-frequency (four to seven migraine headache days per month) and high-frequency (eight to 14 monthly migraine headache days).

Both 120mg and 240mg doses of Lilly’s drug led to a reduction in migraine headache days in low and high-frequency subgroups.

Assessment of various secondary endpoints also showed statistically significant improvements in both subgroups, compared to placebo.

"These collective analyses reflect our continued commitment to aid people living with this serious neurologic disorder."

These secondary endpoint improvements included the proportion of patients with ≥50%, ≥75% and ≥100% decrease in overall monthly migraine headache days from baseline and Emgality’s effect on the quality of life measurements.

Lilly Bio-Medicines Neurology Development vice-president Gudarz Davar said: “Migraine causes people to suffer from substantial pain and impairment, no matter how frequently they occur.

“These collective analyses of more than 1,700 patients with episodic migraine from our Phase III Emgality programme reflect our continued commitment to aid people living with this serious neurologic disorder.”

Emgality is a monoclonal antibody that specifically targets calcitonin gene-related peptide (CGRP).

Last year, the medicine received the US Food and Drug Administration (FDA) approval as a preventive therapy for migraine in adults, and the European authorisation for the prophylaxis of the condition in adults with at least four monthly migraine days.

The FDA is currently reviewing the drug for the preventive treatment of episodic cluster headache in adults.

EVOLVE-1 and EVOLVE-2 investigated the safety and efficacy of subcutaneous Emgality over six months in episodic migraine patients.

Primary endpoint of the studies was mean change in monthly migraine headache days from baseline over the six-month, double-blind treatment phase.