The approval of REYVOW is significant because it represents the first new class of acute migraine treatment approved by the FDA in more than two decades

INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).
“Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like REYVOW, which is why we are proud of today’s approval and Lilly’s continuing contribution to the migraine community,” said Gudarz Davar, M.D., vice president, neurology development, Lilly Bio-Medicines. “New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”
As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for REYVOW. Abuse potential refers to the likelihood that abuse will occur with a particular drug product or substance with CNS activity. Consistent with the FDA’s guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of REYVOW were associated with less drug liking when compared to alprazolam, but more than placebo. The recommended controlled substance classification for REYVOW is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of today’s FDA approval, after which REYVOW will be available to patients in retail pharmacies.
“As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating,” said Jan Brandes, M.D., MS, FAAN, assistant clinical professor, Department of Neurology, Vanderbilt University. “With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like REYVOW is an important development for physicians and the patients we treat.1,2,3,4”
The New Drug Application (NDA) for REYVOW included data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of REYVOW for the acute treatment of migraine in adults. Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom (MBS; patient selected from nausea, sensitivity to light, or sensitivity to sound) at two hours following administration of REYVOW in comparison to placebo. Treatment emergent adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia (tingling or numbing sensation on the skin), sedation (sleepiness or drowsiness), nausea and/or vomiting and muscle weakness. See additional Important Safety Information below.
The REYVOW Phase 3 development program, including the open-label GLADIATOR study, involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks.
“For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds,” said Patrik Jonsson, senior vice president and president, Lilly Bio-Medicines. “The approval of REYVOW is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens.”
About REYVOW ™ (lasmiditan) REYVOW is a new oral treatment that binds to 5-HT1F receptors with high affinity and is approved by the FDA for the acute treatment of migraine, with or without aura, in adults. Its therapeutic effects are presumably mediated by agonist effects at this receptor; however, the precise mechanism is unknown. REYVOW is not indicated for preventive treatment of migraine. Once available, REYVOW can be prescribed to patients in oral doses of 50 mg, 100 mg, and 200 mg as needed.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about REYVOW (lasmiditan) as an acute treatment for patients with migraine and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Commercialization and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the company’s ability to effectively commercialize REYVOW in the U.S.; delays or problems in the supply or manufacture of REYVOW; obtaining and maintaining appropriate pricing and reimbursement for REYVOW; complying with applicable U.S. regulatory requirements; any delays in, or the outcome of, scheduling by the U.S. Drug Enforcement Administration (DEA) for REYVOW; and other risks and uncertainties affecting the company. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
2019 © Lilly USA, LLC 2019. All rights reserved
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1. Cameron C, Kelly S, Hsieh S-C, et al. Triptans in the acute treatment of migraine: a systematic review and network meta-analysis. Headache. 2015;55(suppl 4):221-235.
2. Ferrari MD, Goadsby PJ, Roon KI, et al. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002;22:633-658.
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6. Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL, and resource use amongst chronic and episodic migraineurs. Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301.
7. Lipton RB, Bigal ME, Diamond M, et al., Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
8. Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013. Journal of Pain. 2017;57:60.

Refer to: Jen Dial; dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly Bio-Medicines)
Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investor Relations)
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