Lilly's Emgality Fails to Demonstrate Superiority Over Pfizer's Nurtec ODT in Head-to-Head Migraine Prevention Trial

On June 16, Eli Lilly announced the results of the CHALLENGE-MIG clinical trial comparing Emgality (galcanezumab) head-to-head with Nurtec ODT (rimegepant orally disintegrating tablets) for the preventive treatment of episodic migraine in adults. Emgality did not meet the primary endpoint of the study, defined as the proportion of subjects in the Emgality group achieving a 50% or greater reduction in monthly migraine days being statistically superior to Nurtec ODT. This is the first and only trial in its class to compare two calcitonin gene-related peptide (CGRP) antagonist therapies.

Emgality is a monoclonal antibody (mAb) that inhibits the action of CGRP by directly binding to it, while Nurtec ODT exerts its therapeutic effect by binding to and blocking the CGRP receptor (CGRPR). Emgality is administered via injection, whereas Nurtec ODT is taken orally.

CHALLENGE-MIG is a 3-month Phase IV double-blind clinical study evaluating the efficacy and safety of Emgality versus Nurtec ODT in the preventive treatment of episodic migraine in adults. A total of 580 subjects were randomized to receive either 4 doses of Emgality 120 mg (two loading doses followed by once-monthly injections for two months) or 45 doses of Nurtec ODT 75 mg (one tablet taken every other day). Additionally, patients in the Emgality group received placebo ODT, while those in the Nurtec group received placebo injections.

The headache relief was similar between the two groups of patients. However, in this 3-month study, Emgality demonstrated clinically meaningful efficacy and safety, consistent with the previous 6-month study of Emgality. Moreover, Emgality performed better on key secondary endpoints in this 3-month trial. The safety profiles of Emgality and Nurtec ODT were consistent with the previously reported safety profiles of the two treatments, with no new safety-related findings.

The emergence of CGRP/CGRPR inhibitors is gradually opening up the migraine market, which reached a market size of $3.171 billion in 2022. AbbVie, Pfizer, and Eli Lilly and Company are the leading players in this field.

AbbVie's three products, Ubrelvy (ubrogepant), Qulipta (atogepant), and Botox (Botulinum Toxin Type A), have covered all migraine populations. Pfizer acquired Biohaven for approximately $11.6 billion, obtaining the latter's CGRP portfolio, including Rimegepant, Zavegepant, and five preclinical programs. Meanwhile, Eli Lilly is attempting to achieve superiority in this field through head-to-head trials.

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