The drug significantly reduced monthly migraine days and use of acute migraine medications versus placebo in studies.
The approval of the Food and Drug Administration (FDA) clears the use of monthly Aimovig injection shots for adults suffering with migraine.
The drug is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.
"Having a treatment created to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine", said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School in New Hampshire, in a statement.
In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.
Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick autoinjector, and does not require a loading dose.
Amgen and Novartis have beaten Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab to market, with first-mover advantage in a market for CGRP drugs that is expected to grow from zero to $4bn or more by 2026.
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According to an FDA release, the monoclonal antibody was evaluated in three clinical trials that demonstrated effectiveness for those with episodic and chronic migraine compared to placebo. Most commonly reported side effects were injection site reactions and constipation.
In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients.
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. The companies expect approval in the European Union in the coming months.
That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups.
Amgen's pricing strategy "appears to play into (an) appropriate framework of lower gross pricing", Jefferies analyst Michael Yee said in a research note. We expect the drug to boost Amgen's top line going forward.
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!