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Eli Lilly To Launch Head-to-head Study Comparing Once-monthly Injectable Emgality With Nurtec ODT

Eli Lilly and Co. (LLY) announced Tuesday that it will conduct a head-to-head study comparing once-monthly injectable Emgality (galcanezumab-gnlm) with Nurtec ODT (rimegepant), an orally disintegrating tablet patients take every other day.

This study will help to advance the science of migraine treatment and aid the understanding of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) compared to oral CGRP receptor antagonists in the prevention of migraine.

CGRP is a protein in the brain thought to play a key role in migraine. Emgality binds to this protein, preventing it from attaching to the CGRP receptors, whereas Nurtec ODT blocks the receptor for this protein. This study aims to answer important questions that will help clinicians and patients make more informed treatment decisions on the path to more migraine-free days.

The study, which is the first head-to-head clinical trial comparing two medications targeting CGRP, is a multi-site, randomized, double-blind, double-dummy, parallel-group Phase 4 study in patients who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine with or without aura.

There will be two treatment arms: Emgality 120 mg once-monthly injection, with an initial 240 mg loading dose, and Nurtec ODT 75 mg, taken every other day. The study's primary endpoint is 50% reduction in monthly migraine headache days. Enrollment is expected to begin later this year.

Emgality is a monoclonal antibody that selectively binds to CGRP and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. In June 2019, Emgality was approved by the FDA for the treatment of episodic cluster headache in adults.

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