Antibody therapy for migraine prevention set for marketing authorisation

Antibody therapy for migraine prevention set for marketing authorisation

The first monoclonal antibody therapy for migraine prevention, Aimovig, has been recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Aimovig is a new medicine that will help migraine prevention 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 European population suffers from migraine, a condition which sees patients experience recurrent episodes of intense, throbbing headache often on one side of the head.

The pain can be so intense that it can often cause visual disturbances known as an ‘aura’, as well as light sensitivity, nausea and vomiting.

Treatments to tackle migraine

There is no exact cause known of how migraines occur, but it is believed to be a neurovascular disorder within both the brain and the blood vessels of the head. It is most frequent in women and has a strong genetic component.

There is no known cure, but there are many treatments available to both tackle the symptoms and reduce the frequency of migraine days.

However, the existing prophylactic treatments are associated with variations in effectiveness, as well as poor safety and tolerability.

What are the benefits of Aimovig?

Aimovig was studied in two pivotal trials, involving 667 patients with chronic migraine and 955 with episodic migraine.

Following three months of treatment, patients with chronic migraine showed a reduction of 2.5 monthly migraine days on average compared to placebo, while patients with episodic migraine saw a reduction of either 1.3 or 1.8 days, depending on the dose taken.

The EMA has advised that patients should only take Aimovig if they 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.

What’s the next step?

Now the marketing authorisation has been sent, the CHMP opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

Once this authorisation has been granted, decisions about price and reimbursement will take place at member state level, taking into account the potential role/use of this medicine in the context of the national health system of that country.

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