Eli Lilly migraine drug Emgality approved by FDA

A human brain and its millions of small nervesJohan Swanepoel/Shutterstock

• The FDA just approved a new preventative migraine medication made by drug giant Eli Lilly. 
• The drug, Emgality, is the third in a competitive new class of medication going after the 38 million Americans who have migraines. Around a third of those people would be eligible for these preventive treatments.
• Watch Lilly trade in real time here. 

The FDA just approved a migraine treatment that’s the first of a new class of medications.

The drug is called Emgality, and it’s made by drug giant Eli Lilly.

Until May, there weren’t any drugs available today that were originally approved for alleviating migraines, though other treatments — including Botox and anti-seizure medications — have been used. Pain relievers can also help treat some of the symptoms of migraines.

The drug — and its competitors — target CGRP, short for calcitonin gene-related peptide.

CGRP isn’t exactly a new target. CGRP has been known to play a significant role in migraines since the 1980s and 1990s, though it’s taken some time to develop the technology that can leverage it.

But in the past few months, the FDA has approved three preventative medications that act on the target.

Lilly’s is the latest, and is a monthly injection. The company found in two phase 3 trials that patients on the drug had between a 3.6 and four-day reduction in migraine days per month (to be eligible, patients had to have between four and 14 migraine days per month).

That’s compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups. 11.5% of the patients on one of the trials had a 100% reduction in their migraines, compared to the 5.7% of those who received placebo and experienced a 100% reduction in migraines. 

So far, Aimovig, a drug made by Amgen and Novartis, and Teva’s Ajovy have come in at a price of $575 for a monthly dose, or about $6,900 a year. Analysts expect Aimovig alone to reach $1 billion in annual sales by 2022. Amgen’s been giving out two months of free samples, followed by a patient assistance program that provides up to a year of coverage if commercial insurance doesn’t cover it. 

Teva took a similar approach with a savings card that lets patients access Ajovy for free until December 2019. 

Wei-Li Shao, the vice president of Lilly’s neuroscience business told Business Insider, that the company also plans to provide starter kits of Emgality to doctors’ offices that treat migraines.

Beyond that, Lilly also plans to have a patient access program that provides up to 12 months of Emgality for free. On the competitive nature of the space, Shao said that it gave patients a choice in which medication might work best for them. 

“We think that’s a good thing,” Shao said. He said the company is also in conversations with organizations responsible for paying for medications, such as pharmacy benefit managers, to strike up “value-based agreements” in which Lilly would get paid for a medication based on how well it reduces migraines in a particular patient.

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