Eli Lilly has initiated a real-world evidence study, named TRIUMPH, to compare Emgality (galcanezumab-gnlm) to other migraine preventive treatments.
The study will assess the long-term effectiveness of Lilly’s drug in individuals on routine medical care who are switching to a new migraine prevention therapy.
Emgality is a monoclonal antibody designed to selectively attach to calcitonin gene-related peptide.
The drug received the US Food and Drug Administration (FDA) approval in September 2018 to prevent migraine in adults. It also secured FDA authorisation for episodic cluster headache treatment in June.
TRIUMPH will assess the drug in 2,850 patients at clinical sites in the US, Europe and Asia. Over two years, the study will monitor prescribing and treatment choices for migraine preventive drugs.
It will also compare switching patterns and discontinuation rates between Lilly’s drug, other approved CGRP antibodies, botulinum toxin A or B, and oral migraine preventive therapies.
Analyses will be carried out to track decreases in monthly migraine headache days, acute medication outcomes, and other migraine treatment use patterns.
The study is designed to investigate patient-reported outcomes of migraine burden, quality of life and overall treatment satisfaction.
Lilly Bio-Medicines senior vice-president and president Patrik Jonsson said: “It’s important for us to examine the real-world impact of our therapies outside of a formal, clinical trial setting.
“By tracking physician and patient treatment decisions in the real-world, the results from TRIUMPH will contribute to a more comprehensive understanding of the real-world benefit of Emgality and its comparative effectiveness as a long-term treatment option.”
In August this year, the company reported positive findings from the Phase III CONQUER study of Emgality in patients who failed prior migraine preventive treatments.