Lilly's Emgality (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults
INDIANAPOLIS, Eli?Lilly and Company (NYSE: LLY) announced today 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.1 Emgality offers a once-monthly, self-administered, subcutaneous injection.1 Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.1
Experience the interactive multimedia news release here: https://www.multivu.com/players/English/8386051-lilly-emgality-fda-approval-migraine-treatment/
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.2,3,4,5,6?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.4,7,8
"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).
EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). REGAIN was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.
EVOLVE-1 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.2, placebo 9.1)1,9
- Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001)
- At least a 50 percent reduction in MHDs in any given month on average (% responders): 62% (N=210) for Emgality 120 mg compared to 39% (N=425) for placebo (p<0.001)
- At least a 75 percent reduction in MHDs in any given month on average (% responders): 39% (N=210) for Emgality 120 mg compared to 19% (N=425) for placebo (p<0.001)
- 100 percent reduction in MHDs in any given month on average (% responders): 16% (N=210) for Emgality 120 mg compared to 6% (N=425) for placebo (p<0.001)
- Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001)
- At least a 50 percent reduction in MHDs in any given month on average (% responders): 59% (N=226) for Emgality 120 mg compared to 36% (N=450) for placebo (p<0.001)
- At least a 75 percent reduction in MHDs in any given month on average (% responders): 34% (N=226) for Emgality 120 mg compared to 18% (N=450) for placebo (p<0.001)
- 100 percent reduction in MHDs in any given month on average (% responders): 12% (N=226) for Emgality 120 mg compared to 6% (N=450) for placebo (p<0.001)
- Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001)
- At least a 50 percent reduction in MHDs in any given month on average (% responders): 28% (N=273) for Emgality 120 mg compared to 15% (N=538) for placebo (p<0.001)
- Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the three-month treatment period.
- Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any state patient or pharmaceutical assistance program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (12/31/2020); (ii) the date an AB-rated generic equivalent for Emgality becomes available; or (iii) June 30, 2019, absent a change in Massachusetts state law. If you live in California, the Card expires on the earlier of: (i) the expiration date of this Card (12/31/2020) or (ii) the date an FDA-approved therapeutically equivalent for Emgality or over-the-counter product with the same active ingredients becomes available.
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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SOURCE Eli Lilly and Company