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The FDA has approved Emgality, a subcutaneous injection, once a month, self-administered, 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 preventive treatment" Christi Shaw, President of Lilly Bio-Medicines, said in the release. "For more than two decades, Lilly has recognized this unmet need and we have worked tirelessly to develop a new option specifically designed for migraine prevention. With this approval, we are pleased to offer a preventive treatment option to adults living with this disease. "
Eggality's approval (Galcanezumab-Gnlm, Eli Lilly and Company) was based on three Phase 3 clinical trials that evaluated the efficacy and safety of the drug (EVOLVE-1, EVOLVE-2 and REGAIN).
EVOLVE-1 and EVOLVE-2 were placebo-controlled, double-blind, 6-month studies, including patients with episodic migraine, defined as 4 to 14 days of migraine per month, according to the release. . REGAIN was a 3-month, double-blind placebo-controlled placebo-controlled study including patients with chronic migraine defined by at least 15 days of headache per month with at least 8 days of migraine per month, according to the communicated. The studies included more than 2500 participants.
The FDA has recently approved Emgality, a subcutaneous injection administered once a month, for the preventive treatment of migraine in adults.
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In all three studies, patients were randomized to receive either placebo once a month, 120 mg of galcanezumab-gnlm after an initial loading dose of 240 mg, or 240 mg of galcanezumab-gnlm, depending on the release. Studies have shown that patients receiving galcanezumab-gnlm had a greater decrease in the percentage of monthly migraine days than those receiving placebo.
Adverse effects of galcanezumab-gnlm included injection site reactions and hypersensitivity reactions, such as rash, hives, and dyspnea, depending on the release. Galcanezumab-gnlm should not be used in patients with severe hypersensitivity, depending on the release.
Manufacturers recommend that two consecutive subcutaneous injections of 120 mg galcanezumab-gnlm be used once as a loading dose, followed by doses of 120 mg per month.
In the United States, galcanezumab-gnlm is quoted at $ 575 a month or $ 6,900 a year, according to the statement.
"We know that the impact of high deductible and increased direct costs on families is important, and Lilly takes our role seriously in ensuring affordable access to Emgality for the largest number of patients possible, "said Shaw. "Lilly's Choice to Provide Free Emgality for Up to 12 Months to All Eligible Patients Benefiting from Commercial Insurance" [subject to terms and conditions] underlines our 25-year commitment to recognizing and responding to the needs of migraine sufferers.
Galcanezumab-gnlm is expected to be available soon, according to the statement.
Disclosure:
Shaw is employed by Lilly Bio-Medicines.
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