FDA Approves Eli Lilly’s Migraine Drug, Which Faces Stiff Market Competition

Eli Lilly Biotechnology Center

The U.S. Food and Drug Administration (FDA) approved Eli Lillys Emgality (galcanezumab-gnlm) for migraine prevention.

Lilly is lagging in this area, with the drug third-to-market behind Amgen and Novartis Aimovig (erenumab-aooe) and Teva Pharmaceuticals Ajovy (fremanezumab). They are all a new class of drug that blocks the calcitonin gene-related peptide receptor (CGRP-R).

Aimovig, which was approved in May, is 70 mg self-administered once a month by way of Amgen’s SureClick autoinjector. Ajoy, approved this month, is also an injectable, but only requires injections once every three months. Lilly’s Emgality is 120 mg injected once a month.

Lilly says Emgality will be available to patients soon. Patients with commercial insurance policies may be eligible to receive the drug for up to a year free as part of the company’s patient support program. The drug will be available via retail pharmacies.

“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” stated Christi Shaw, president of Lilly Bio-Sciences. “For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”

It would seem that Teva’s Ajoy would have a market advantage in that it only requires, in most cases, an injection every three months. With the field suddenly deluged with competitors, pricing is also likely to be a factor. In the U.S., Lilly indicates Emgality’s price will be $575 once a month, which comes to $6,900 annually.

In comparison, Teva has indicated that the U.S. Wholesale Acquisition Cost (WAC) for Avoy will be identical, $575 per month and $1,725 for a quarterly dose. It also is offering a free offer to select patients with commercial insurance, as well as a financial support program, Teva Shared Solutions. The price is the same for Amgen’s Aimovig.

“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,” stated Shaw. “Lilly’s choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine.”

Wei-Li Shao, Lilly’s vice president of neuroscience had noted that in their clinical program, one out of seven patients didn’t experience any migraines in a month on the drug. It also has the 12-month free program and in their trials, 90 percent of patients said Emgality’s injection pen is easy to use.

Lilly’s Emgality approval was built on two Phase III clinical trials, EVOLVE-1 and -2 for episodic migraine and another Phase III trial in patients with chronic migraine, REGAIN. The EVOLVE trials were six-month, double-blind, placebo-controlled trials with adults with episodic migraine, which is defined as four to 14 migraine headache days per month. REGAIN was a three-month, double-blind, placebo-controlled trial of adults with chronic migraine, defined as at least 15 headache days per month with at least eight migraine headache days per month.

It’s estimated that more than 30 million adults in the U.S. have migraine, with women affected three times more often than men.

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