The FDA has approved Emgality, a once-monthly, self-administered, subcutaneous injection, for the preventive treatment of migraine in adults, according to a press release issued by the manufacturer.
“Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking a preventive treatment,” Christi Shaw, president of Lilly Bio-Medicines, said in the release. “For more than 2 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 approval of Emgality (galcanezumab-gnlm, Eli Lilly and Company) was based on three phase 3 clinical trials that assessed the drug’s efficacy and safety (EVOLVE-1, EVOLVE-2 and REGAIN).
EVOLVE-1 and EVOLVE-2 were 6-month, double-blind, placebo-controlled studies including patients with episodic migraine, which was defined as 4 to 14 migraine headache days per month, according to the release. REGAIN was a 3-month, double-blind, placebo-controlled study including patients with chronic migraine which was defined as at least 15 headache days per month with at least 8 migraine headache days per month, according to the release. The studies included more than 2,500 participants.
The FDA recently approved Emgality, a once-monthly, self-administered, subcutaneous injection, for the preventive treatment of migraine in adults.
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In all three studies, patients were randomly assigned to receive either once-monthly placebo, 120 mg of galcanezumab-gnlm after an initial loading dose of 240 mg, or 240 mg of galcanezumab-gnlm, according to the release. The studies showed that patients receiving galcanezumab-gnlm had a greater decline in the percentage of monthly migraine headache days than those receiving placebo.
Adverse events of galcanezumab-gnlm included injection site reactions and hypersensitivity reactions, such as rash, urticaria and dyspnea, according to the release. Galcanezumab-gnlm should not be used in patients with serious hypersensitivity, according to the release.
The manufacturers recommend that two consecutive subcutaneous injections of 120 mg of galcanezumab-gnlm each be used once as a loading dose, followed by 120-mg doses monthly.
In the United States, galcanezumab-gnlm is listed as $575 once-monthly or $6,900 annually, according to the release.
“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible,” Shaw said. “Lilly's choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance [subject to terms and conditions] underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine.”
Galcanezumab-gnlm is expected to be available soon, according to the release.
Shaw is employed by Lilly Bio-Medicines.