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European Medicines Agency

First monoclonal antibody for migraine recommended for approval by EMA

The European Medicines Agency’s Committee (EMA) for Medicinal Products for Human Use has recommended granting a marketing authorisation for erenumab (Aimovig; Novartis), the first monoclonal antibody therapy for migraine prevention. 

In clinical trials of the drug, patients with chronic migraine, defined as a migraine that occurs on more than 15 days per month, experienced an average reduction of 2.5 monthly migraine days compared with placebo.

Patients with episodic migraine, who experience fewer than 15 migraine days each month, found an average reduction of 3.2 or 3.7 days depending on whether they were given 70mg or 140mg of erenumab.

Around 15% of the European population is estimated to have migraines, which are typified by intense headaches often accompanied by sensory disturbances that can include perceived flashes of light, blind spots and tingling in the hands or face.

Monoclonal antibodies bind to specific cells or proteins, and induce the body’s immune system to attack that cell or protein.

The EMA’s recommendation will now be forwarded to the European Commission, who will decide on whether to adopt an EU-wide marketing authorisation for this latest example of the drug class.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204955

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