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The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Aimovig (erenumab).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) said the drug was the first human monoclonal antibody therapy for preventing migraine.
Aimovig, produced by Novartis Europharm, belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP) – a molecule that is involved in migraine attacks.
It is estimated that approximately 15% of the world’s population experience migraines. Migraine can substantially impair a patient’s ability to function physically, at work or school and socially.
Existing prophylactic treatments for migraine are frequently associated with variable efficacy and poor safety and tolerability. There is therefore an unmet medical need for new treatment options.
The benefits and safety of Aimovig were studied in two trials involving 667 patients with chronic migraine and 955 with episodic migraine. After three 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 either 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.
Aimovig should only be taken by patients who have at least four migraine days a month. It is a solution for injection that is administered once a month. Patients can inject themselves after appropriate training.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.