US FDA approves new drug for prevention of migraines

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A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday.

Aimovig is the first in a clutch of four calcitonin gene-related peptide (CGRP) drugs to be approved by the FDA.

The U.S. Food and Drug Administration on Thursday approved Amgen Inc's drug Aimovig for the prevention of migraine headaches in adults.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.

Aimovig is produced by Amgen and Novartis, and it's expected to be available within a week, according to The New York Times.


"Aimovig provides patients with a novel option for reducing the number of days with migraine", said Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

Amgen Inc is also in collaboration with the Swiss pharmaceutical firm Novartis that can help in commercializing the medication rapidly and across the globe.

In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments.

Before the trial, patients had about 18 migraine days.

The approval for sale in the European Union is expected in the next few months.


The most common side effects were injection site reactions and constipation. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications.

Coming in June: Practical Pain Management's cover story addresses the new CGRP migraine-inhibitor class, featuring perspectives from Amgen, Novartis, Lilly, Teva, Allergan and more!

The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine".

Representatives of the American Management on sanitary inspection behind quality of foodstuff and medicines has issued a statement about the fact that regular injections of the new drug is able to relieve patients from headaches and chronic migraines.


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