European Headache Alliance

Lilly’s Emgality Approved

INDIANAPOLIS, Sept. 27, 2018

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults.

Emgality offers a once-monthly, self-administered, subcutaneous injection. Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Emgality will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program (governmental beneficiaries excluded; subject to terms and conditions*). Emgality will be available for pickup at retail pharmacies.

Migraine is a disabling, neurologic disease that affects more than 30 million American adults. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually, yet migraine remains under-recognized and under-treated.

"Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment," said Christi Shaw, president, Lilly Bio-Medicines. "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."

The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN).

To learn more about EVOLVE 1, EVOLVE 2 and REGAIN and everything about the important safety information please visit:

https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval

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