Eli Lilly may not be first to the market with its next-gen migraine drug Emgality, but with an approval Thursday, the drugmaker still believes it can be the “treatment of choice” for migraine prevention.
The FDA endorsed Emgality as a once-monthly migraine prevention injection for adults. The drug will carry the same list price as Amgen’s already approved Aimovig and Teva’s Ajovy—$6,900 per year—setting up a three-way race among the drugmakers in a field where patients are in dire need of new options, the companies say.
In an interview, Lilly VP of neuroscience Wei-Li Shao said several factors will help Emgality beat out its rivals. One in seven patients in clinical testing didn’t experience any migraines in a month, he said, offering them “migraine freedom.” Additionally, Lilly is rolling out a 12-month free drug program to help patients access the drug right away. Lastly, 90% of patients in clinical trials reported that Emgality’s pen is easy to use, according to Shao.
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In clinical testing, one-third of trial patients on Emgality saw their migraine headache days drop by at least 75%, according to Lilly senior medical fellow Eric Pearlman. For two-thirds, Emgality cut migraine days by at least 50%, he said. The drug won European approval last week.
Emgality follows Amgen's Aimovig and Teva's Ajovy into the market after their approvals in May and earlier this month, respectively. In a recent note, Jefferies analyst David Steinberg wrote that Aimovig "has had an impressive launch to date–driven by payer 'friendly' pricing, significant pent up demand ... and a major sampling program to quickly onboard patients prior to potential competition from Ajovy and Emgality."
Even as patients quickly start on Amgen's med, the analyst sees a "major opportunity" for the competitors because of a large patient base. He wrote that about 15 million patients in the U.S. could benefit from the class of migraine prevention meds.
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Lilly is expecting “quite a bit of demand for Emgality from the get-go,” Shao said. And over the long run, he said the company expects strong demand because millions of patients are affected by migraines.
To support the rollout, Lilly plans to ship thousands of loading dose sample kits to doctors “within weeks,” Shao said, so that patients can start their treatment immediately. They’ll be able to activate the 12-month free-access program at the same time.
Aside from Amgen, Teva and Eli Lilly, Alder BioPharmaceuticals has a CGRP drug program in development. Also on Thursday, a judge dismissed a patent infringement lawsuit brought by Teva against Lilly that sought to prevent the launch of Emgality, according to Reuters.