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Amgen, Novartis' migraine drug wins US FDA approval as preventive treatment

The U.S. Food and Drug Administration approved Amgen Inc. and Novartis AG's Aimovig for the preventive treatment of migraine in adults.

Migraine is a neurological disease that involves recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors.

The drug, which is a self-administered once monthly via Amgen's SureClick autoinjector device, will come in 70 milligrams and 140 mg doses. The U.S. list price of Aimovig is $575 for once monthly 70 mg or 140 mg single-use prefilled SureClick autoinjectors, or $6,900 annually.

Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo in phase 2 and 3 studies in chronic and episodic migraine.

Novartis said the treatment is expected to be available to patients in the U.S. within one week.

The company expects approval in the coming months in the EU, where Aimovig's marketing authorization application is under review by European Medicines Agency.

Novartis entered into a global collaboration with Amgen in August 2015 to develop and commercialize treatments in the field of migraine and Alzheimer's disease. The collaboration was expanded in April 2017 to include co-commercialization of Aimovig in the U.S.