Lilly’s preventative migraine treatment receives US FDA green light

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/image_jungle)
(Image: Getty/image_jungle)

Related tags: Migraine, Fda, FDA approval, preventative treatment, positive opinion, regulatory approval

Eli Lilly’s migraine treatment was approved by the US FDA, closely following a positive CHMP opinion, and will potentially be made available without cost for the first year.

The US Food and Drug Administration approved Emgality, for the dose of a 120mg in adults for the preventative treatment of migraines.

Gudarz Davar, VP of the neurology development at Lilly Bio-Medicines, told us that the efficacy and safety of Emgality was demonstrated in two Phase III clinical trials in patients with episodic migraines and one Phase III clinical trial in patients with chronic migraines. There was also one 12-month open-label safety study.

“In all three efficacy clinical trials, Emgality reduced mean monthly migraine headache days in the first month and every following month in the treatment period compared to placebo,”​ said Davar.

He further explained that in these studies more than one-third of patients saw a 75% reduction in monthly migraine headaches.

Emgality is a patient-administered, once-monthly, injection. Lilly’s drug, Emgality, is a humanized monoclonal antibody designed to bind to the calcitonin gene-related peptide (CGRP). The drug was created to help prevent migraines by blocking the CGRP without interacting with the CGRP receptor.

Population and pricing

Davar stressed to us the serious nature of the condition, “Migraines affect more than 100 million people globally, making [them] the third most prevalent disease in the world.”

In a press release, Christi Shaw the president of Lilly Bio-Medicines stated that roughly 10% of people who suffer from migraines take preventative treatment.

However, if price is causing the 90% of patients not seeking preventative treatment, that percentage may drop as Emgality will be available to patients shortly and free for 12 months to patients with commercial insurance as part of Lilly’s patient support program​.

The estimated unadjusted cost of Emgality will be $575 (€495) monthly and $6,900 annually. Shaw said further in a press release, "We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible."

Emgality will join Teva and Novartis that also have drugs approved in the CGRP receptor field. Novartis was the first company to experience regulatory success​, after its drug, Aimovig, received approval by the European Commission. Teva also received approval​ for its quarterly and monthly treatment Ajovy.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion for Emgality on September 21, 2018. The positive opinion is the first step towards an approval in Europe.

Related topics: Markets & Regulations, Emerging Markets

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