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For Episodic Migraine, Emgality Shows Efficacy but Not Superiority
In a head-to-head clinical trial of Emgality (galcanezumab-gnlm) and Nurtec ODT (rimegepant), Emgality did not meet the study’s primary endpoint of statistical superiority in the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. Rather, response rates for the two calcitonin gene-related peptide (CGRP) antagonist therapies were similar, Emgality maker Eli Lilly and Company announced.
Administered by injection, Emgality is a monoclonal antibody that binds to CGRP to inhibit its effects. Nurtec ODT is a gepant medication that binds to and blocks the CGRP receptor. An orally disintegrating tablet, Nurtec ODT is taken by mouth.
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The 3-month CHALLENGE-MIG trial was a double-blind study that assessed the efficacy and safety of Emgality and active comparator Nurtec ODT in adults with episodic migraine. Researchers randomized 580 participants to either 4 injections of Emgality 120 mg (a loading dose of two injections followed by two monthly injections) or 1 oral tablet of Nurtec ODT 75 mg every other day. In addition, patients assigned to Emgality received placebo tablets, and those assigned to Nurtec ODT received placebo injections.
Although Emgality did not demonstrate superior response for the primary endpoint, it showed clinically meaningful efficacy and safety consistent with previous 6-month studies. Eli Lilly also reported that Emgality performed numerically better than Nurtec ODT on key secondary endpoints in the 3-month trial.
The safety profiles for both medications were consistent with previous reports.
Eli Lilly said it will release full CHALLENGE-MIG trial results later this year.
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