Eli Lilly and Company announced 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. 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).
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)
· 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)
EVOLVE-2 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.1, placebo 9.2)
· 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)
REGAIN (Over Months 1 to 3 - baseline migraine headache days: Emgality 19.4, placebo 19.6)
· Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg...
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