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September 28, 2018 – The FDA has approved the third of a new type of medication to prevent migraine headaches in adults.
Galcanezumab-gnlm (Emgalité) targets the calcitonin gene-related peptide (CGRP), a molecule produced in the nerve cells of the brain and spinal cord. The FDA has approved two other CGRP medications for migraine – erenumab (Aimovig) and fremanezumab-vfrm (Ajovy) – earlier this year.
In a press release, drug manufacturer Eli Lilly and Co. says the injectable drug will be made available to patients "shortly after approval".
"I have lived with migraine for over 30 years and have seen first-hand the impact it has on your life, including the ability to carry out daily activities," said Jill Dehlin, president of the organization. Patient Leadership Council of the National Headache Foundation. in 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. "
In two Phase 3 clinical trials that included more than 1,700 patients with episodic migraine, those who received 120 or 240 milligrams of the drug had significantly fewer migraine days per month than those who received a placebo.
A third trial, including more than 1,100 patients with chronic migraine, gave similar results.
The problems reported in the three studies included pain, reactions, and redness of the skin at the site of the shot.
The company says the US selling price will be $ 575 a month or $ 6,900 a year. Patients with commercial insurance could receive the drug for free for 12 months as part of their patient support program.
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