The US FDA approves Eli Lilly’s calcitonin gene-related peptide (CGRP) antagonist galcanezumab-gnlm (Emgality).
Out of all migraine sufferers, just approximately 10% currently take a preventive medicine, according to Christi Shaw, president of Lilly Bio-Medicines. The US Food and Drug Administration (FDA) seems determined to give them more options. It recently approved () (for the third time in 2018) a calcitonin gene-related peptide (CGRP) antagonist (anti-CGRP) for the prevention of migraines in adult patients.
The latest drug to receive approval is galcanezumab-gnlm (Emgality) from Eli Lilly. The previous two FDA approvals went to erenumab (Aimovig) from Amgen and Novartis, and fremanezumab-vfrm (Ajovy) from Teva Pharmaceuticals. Emgality also received recommended marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use in September.
A humanized monoclonal antibody, Emgality was approved based on the results of the EVOLVE-1 and EVOLVE-2 phase 3 studies, which included more than 1700 patients with episodic migraines, and the REGAIN trial, which included more than 1100 patients with chronic migraines. Participants in all trials receiving the drug experienced significantly greater reductions in monthly migraine headache days than those who received matching placebo.
Eli Lilly will begin selling the injectable drug "shortly after approval " at a list price of $575 per month and $6900 per year. According to the company, patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program.