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The US Food and Drug Administration (FDA) has approved galcanezumab-gnlm, an antagonist of calcitonin gene-related peptides (CGRP) (Emgalité, Eli Lilly and Co) for the prevention of migraine in adult patients, reports the manufacturer.
This marks the third approval by the agency this year of an anti-CGRP for this indication, following the previous approval of Eenenumab (Aimovig, Amgen and Novartis) and fremanezumab-vfrm (Ajovy, Suits you).
The humanized monoclonal antibody also received the marketing authorization recommended by the Committee for Medicinal Products for Human Use from the European Medicines Agency last week.
The FDA's approval is for a subcutaneous injection of 120 mg galcanezumab self-administered. The recommended dose is 240 mg once in a loading dose, administered in two consecutive injections of 120 mg each, followed by monthly injections at 120 mg.
It is contraindicated in patients with "serious hypersensitivity" to the drug or to any of its excipients, notes the company in a press release.
He added that the injectable drug will be made available to patients "shortly after approval".
"I have lived with migraine for over 30 years and have experienced first-hand the impact it has on your life, including the ability to perform daily activities." said Jill Dehlin, president of the Patient Leadership Council of the National Headache Foundation. the same version.
"Those of us who live with migraine have spent years hoping for new treatment options and I am grateful for the efforts of researchers, researchers, and clinical trial patients who have helped make this possible." added Dehlin.
Phase 3 Tests
As reported at the time by Medscape Medical News, the detailed results of three phase 3 trials evaluating galcanezumab were presented at the annual scientific meeting of the American Headache Society in 2017.
In EVOLVE-1 and EVOLVE-2, which included more than 1700 patients with episodic migraine, participants receiving 120 or 240 mg of active drug experienced significantly greater reductions in monthly migraine days than those receiving a corresponding placebo.
Similar results were presented in the REGAIN trial, which included more than 1,100 patients with chronic migraine.
Adverse events reported in the three studies included injection site pain, reactions, and erythema.
The company says the US selling price of the drug will be $ 575 once a month or $ 6900 a year. However, "patients with commercial insurance are candidates to receive Emgality for up to 12 months as part of Lilly's Patient Support Program," said the manufacturer.
"Despite the devastating impact of migraine, only about 10% of people living with the disease are currently taking preventive treatment," said Christi Shaw, president of Lilly Bio-Medicines, in the statement.
"With this approval, we are pleased to offer a preventive treatment option to adults living with this disease," she added.
Follow Deborah Brauser on Twitter: @MedscapeDeb.
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