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Eli Lilly announces that the European Commission (EC) has authorized the marketing of galcanezumab (Emgalité) as a preventive treatment for migraine in adults suffering from at least four days of migraine per month.
Galcanezumab is a humanized monoclonal antibody that binds to peptide linked to the calcitonin gene (CGRP, for its acronym in English), associated with episodes of migraine, blocking its function.
It is administered by a monthly subcutaneous injection that the patient can be applied with a pen or pre-filled syringe.
In all three clinical trials, galcanezumab showed significantly reduce the monthly average of migraine days and an improvement in functionality compared to placebo.
"Migraine is a disease that can become disabling with limited treatment options. This approval is another milestone for galcanezumab and offers the opportunity to reduce the impact migraine in patients who suffer from it and improve their quality of life ", states José Antonio Sacristán, medical director of Lilly in Spain.
Clinical tests
The marketing authorization is based on data obtained from the studies Evolve-1 and Evolve-2, two Phase III placebo-controlled clinical trials six months double blind comparison each in migraine patients episodic; and the study regain, A try three months double-blind placebo-controlled study in migraine patients chronic.
The main objective of each trial was to determine whether treatment with galcanezumab could result in a significant change in the monthly mean migraine days compared with placebo.
The three studies they reached the main goal, so that patients treated with galcanezumab achieved a significant reduction in monthly average migraine during the first month and each subsequent month during the double-blind treatment period compared to placebo.
Results of effectiveness
According to the results of the studies Evolve-1 and Evolve-2, which evaluated patients with episodic migraine, the majority of patients (approximately 60%) treated with galcanezumab achieved on average reduce at least 50% migraine days per month in any month versus 38.6% and 36% of placebo-treated patients, respectively.
In these studies, more than one-third of the patients managed, on average, to reduce at least 75% the number of migraine days per month compared with 19.3% and 17.8% of patients treated with placebo Evolve-1 and Evolve-2, respectively.
One in seven patients (15.6%) were able to do without monthly migraine days, regardless of the month, Evolve-1on average compared to 6.2% of placebo-treated patients.
Side effects
The most common drug-related side effects that have been detected they had pain at the injection site (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 moderate in severity.
Frequent illness
Migraine is considered the third most important disease and the second most disabling disease. It's a neurological disease characterized by recurrent episodes of severe headache lasting 4 to 72 hours, accompanied by other symptoms, including: nausea, vomiting, hypersensitivity to light and sound and spontaneously resolving neurological symptoms called aura.
Episodic migraine is considered a migraine. up to 14 days with migraine per month, while chronic migraine is taken into account when 15 days or more with a headache a month of which at least 8 have migraine characteristics.
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