The FDA Just Approved a Third Migraine Drug—and It’s Free (At Least for Now)

September 28, 2018, 10:16 AM UTC
Migraine, Illustration
Illustration of the migraine process, or migraine attack. External factors trigger the stimulation of the hypothalamus (green area), which triggers the stimulation of neurons innervating the arteries in the meninges (green area round the brain). These neurons release neuropeptides in the lining of these arteries, causing inflammation and dilatation, causing the migraine pain. (Photo by BSIP/UIG via Getty Images)
BSIP/UIG via Getty Images

Migraine sufferers have gone from having no migraine-specific treatments to three new ones this year as the U.S. Food and Drug Administration (FDA) has approved a new drug from Eli Lilly for treating the debilitating headaches.

The approval creates a rare competitive market in the pharmaceutical industry and Lilly, like the companies behind the two previous drugs, is offering it at little or no cost to insured patients for a limited period.

On Thursday, Eli Lilly (LLY) announced the FDA approved Emgality (generic: galcanezumab-gnlm) injections for migraine prevention. On the same day, a federal judge dismissed two patent infringement lawsuits by Teva Pharmaceutical Industries (TEVA) against Lilly related to Emgality. Emgality is also on track for final approval in the European Union.

Galcanezunab inhibits calcitonin gene-related peptide, a molecule that researchers have been targeting since the 1980s. A drug from Amgen approved in May and another from Teva approved earlier in September work on the same principle. All three of the approved migraine drugs require delivery by injection, though Allergan is working on pills that would deliver similar migraine-fighting compounds for preventative and acute treatment. Alder Biopharmaceuticals also has a potential migraine treatment in human trials and another in preclinical research.

Emgality will have a list price of $6,900 a year, in the same range as the Amgen and Teva drugs. Like its competitors, Eli Lilly will offer the drug at little to no cost to insured patients for 12 months (with a price cap) while it wrangles with insurers over prices, Bloomberg reports.

Migraines may affect as many as 39 million Americans, with 4 million Americans suffering daily symptoms, the Migraine Research Foundation claims. Some 15 million Americans might benefit from this year’s new class of migraine drugs, estimates Jeffries analyst David Steinberg. The annual market for migraine drugs could reach $2.2 billion by 2025 according to one recent estimate.

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