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FDA Approves First Preventive Treatment for Migraine

FDA Approves First Preventive Treatment for Migraine

The U.S. Food and Drug Administration (FDA) recently approved Aimovig (erenumab-aooe), the first preventive treatment for migraines in adults, providing patients with a new therapy option to reduce the number of migraine days per month.

Aimovig offers promising relief for this painful and often debilitating condition. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet.

The World Health Organization classifies migraines as one of the top 10 most disabling medical illnesses. Migraine is three times more common in women and affects more than 10% of people worldwide.

Drug Overview and Place in Therapy

The novel self-injectable therapy is in a new class of drugs that targets a protein called calcitonin gene-related peptide (CGRP). This neuropeptide causes inflammation of nerves in the face and head, and dilates blood vessels in and around the brain, producing the pressure and pounding, throbbing sensations often reported by migraine sufferers. Aimovig binds to the CGRP receptor and prevents this painful process.

Drug manufacturer Amgen announced that Aimovig will cost $6,900 per year—$575 for each monthly self-administered injection. Analysts expect that up to 7 million Americans will receive anti-CGRP therapy, with sales predictions of $1.2 billion in 2022.

Two other antibodies that target CGRP are currently under FDA review, with decisions anticipated in 2018.

Efficacy and Safety Data:

Data from three phase 3 studies demonstrated Aimovig was effective for prevention of chronic migraines as well as episodic migraines. In one trial, patients with episodic migraines treated with Aimovig experienced 1.4 to 1.9 fewer migraine days per month compared to placebo. In a second study, 30.3% of patients with episodic migraines saw a 50% or greater reduction in the number of monthly migraines experienced. A third study, performed in patients with chronic migraines, showed 2.4 fewer migraine days per month in patients taking Aimovig compared to placebo.

The most common side effects were injection site reactions and constipation. Detailed Aimovig prescribing information is available here.

Forward-Thinking Strategies to Manage Drug Costs

The approval of Aimovig introduces the first approved biologic therapy into a market previously treated with low-cost, generic oral therapies. Due to the anticipated high impact of this agent, MedImpact’s Pharmacy and Therapeutics Committee reviewed Aimovig prior to approval, and our Emerging Therapeutics Strategy and Health Economics and Outcomes departments completed an advanced budget impact model for our clients.

To learn more about how MedImpact can help you manage high-impact, high-cost drugs, reduce costs and improve care, go to pbm.medimpact.com.

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