Following recent approval by the US Food and Drug Administration (FDA) the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting marketing authorization for Aimovig (erenumab), the first human monoclonal antibody therapy, for migraine prevention.
The drug belongs to a new class of medications that block the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.
The committee’s marketing authorization recommendation is based on findings from two pivotal trials involving 667 patients with chronic migraine and 955 with episodic migraine.
After 3 months of treatment, patients with chronic migraine showed a reduction of 2.5 monthly migraine days on average compared to placebo.
For patients with episodic migraine the reduction was 1.3 or 1.8 days, depending on the dose taken.
The most common adverse events observed were injection site reactions, constipation, muscle spasms, and pruritus.
The once-monthly self-injectable drug is the first in its class to receive FDA approval for migraine prevention.
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Cite this: EU Panel Endorses Erenumab for Migraine Prevention - Medscape - Jun 01, 2018.