Eli Lilly has confirmed that Emgality, a once-monthly monoclonal antibody injection, has been approved by the European Commission for preventive treatment of migraine in adults who have at least four migraine days per month.
The announcement comes just one month after the US Food and Drug Administration also green-lighted the drug in this setting.
As a treatment developed specifically to prevent migraine, Emgality (galcanezumab) blocks the calcitonin gene-related peptide (CGRP) receptor implicated in migraine attacks, and significantly reduces the number of migraine headache days (MHDs) per month.
In studies, the majority of patients experienced at least 50% or greater reduction in MHDs in any given month.
Data from three Phase III trials - EVOLVE-1, EVOLVE-2 and REGAIN - involving 2,901 patients, showed that patients treated with Emgality experienced a significantly greater drop in the average number of monthly migraine headache days compared to placebo.
More than one-third of patients achieved at least a 75% reduction compared to 19.3% and 17.8% of patients on placebo in EVOLVE-1 and EVOLVE-2, respectively.
“Severe migraine is a debilitating disease with limited treatment options. This approval marks another major milestone for galcanezumab, and offers the potential for reducing the number and severity of migraine attacks for patients and improving their quality of life,” said Dr Arash Tahbaz, senior medical director UK and Northern Europe.
Migraine is ranked as the third most common disease in the world and the leading cause of disability among neurological disorders.