Eli Lilly announces that the European Commission (EC) has approved the commercialization of galcanezumab ( Emgality ) as a prophylactic treatment of migraine in adults suffering from at least four days of migraine per month .
Galcanezumab is a humanized monoclonal antibody that binds to the peptide related to the calcite gene (CGRP, for its acronym in English) associated with episodes of migraine, blocks its function
Administered with a month subcutaneous injection which can be applied to the patient with a pen or pre-filled syringe.
In all three clinical trials, galcanezumab has shown significantly reducing the monthly average of migraine days and an improvement in functionality versus placebo.
"Migraine is a Disability with Alternative and Restricted Treatment . This approval is another major milestone for galcanezumab and offers the possibility of reducing migraine's impact in patients suffering from it and improve the quality of life, "says José Antonio Sacristán medical director of Lilly in Spain.
The marketing is based on data from studies Evolve-1 and Evolve-2 two trials Phase III clinical trials controlled by placebo of six months double blind comparison each in patients with episodic migraine ; and study Retrieving a trial of three monthsdouble blind placebo controlled in patients with chronic migraine .
The primary purpose of each attempt was to determine whether treatment with galcanezumab could achieve a significant change in the monthly mean of migraine days compared to placebo.
The three studies reached the primary goal so that patients receiving treatment with galcanezumab achieved a significant decrease in the monthly mean of 19009007 migraine days in the first month and each of the following months during double-blind treatment compared with placebo.
Results of Effect
Unity with the Results of Studies Evolve-1 and Evolve-2 which evaluated patients with episodic migraines, most patients (approximately 60p or hundred) treated with galcanezumab, which was moderately administered to reduce at least 50 percent of migrant days per month in any month compared to 38.6 and 36 percent of patients treated with placebo.
In these studies, more than one third of the patients managed to average by at least 75 percent of the number of migraine monthly days to some extent compared with 19, 3 percent and 17.8 percent of patients treated with placebo in Evolve -1 and Evolve-2 .
One of seven patients (15.6 percent) managed to release from monthly migrants a month in Evolve-1 on average, compared to 6.2 percent of Patients treated with placebo
The most common drug-related adverse events discovered were injection site pain (10.1 / 11.6%), injection site reactions (9.9 / 14.5) , vertigo (0.7 / 1, 2), constipation (1.0 / 1.5), pruritus (0.7 / 1.2) and urticaria (0.3 / 0.1). Most reactions were considered to be of moderate severity.
Migraines are considered the third most common disease and the second most inability disease. It is aneurological disease characterized by recurrent episodes of severe headache lasting between 4 and 72 hours, along with other symptoms including nausea, vomiting, light and sound sensitivity and self-limiting neurological symptoms called aura.
Epistemic migraines are considered when people experience up to 14 days of migraine a month while chronic migraines are taken into account when 15 or more days of headache per month of which at least 8 are migraine.