First-of-its-Kind Migraine Drug Gets FDA Approval

The Food and Drug Administration has approved Aimovig (erenumab-aooe; Novartis and Amgen) for the preventive treatment of migraine in adults. This first-of-its-kind treatment works by binding to the calcitonin gene-related peptide (CGRP) receptor.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”

The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4–14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month). The studies enrolled patients with a history of migraine, with or without aura, according to the International Classification of Headache Disorders diagnostic criteria. Study results showed a decrease in the number of migraine-affected days, disability, and acute medication use for patients with episodic and chronic migraine treated with Aimovig vs placebo.

The most common adverse reactions in clinical studies (occurring in ≥3% of treated patients and more often than placebo) included injection site reactions and constipation. The safety and effectiveness of Aimovig have not been established in pediatric patients. Clinical trials did not include a sufficient number of patients ≥65 years old to determine whether this patient population responds differently to treatment.

Aimovig, a human immunoglobulin G2 (IgG2) monoclonal antibody, is administered once-monthly by subcutaneous injection and is intended for patient self-administration. The injection may be administered in the abdomen, thigh, or upper arm; areas where the skin is tender, bruised, red, or hard should be avoided. The recommended dose is 70mg once monthly, however some patients may benefit from a dosage of 140mg once monthly. The 140mg dose is administered once monthly as 2 consecutive injections of 70mg each.

Aimovig is expected to be available within 1 week in 70mg/mL single-dose prefilled SureClick autoinjectors (packs of 1 or 2 autoinjectors) and 70mg/mL single-dose prefilled syringes (packs of 1 or 2 syringes). The 2-pack presentations are intended for patients who require the 140mg dose. Patients should be properly trained on how to prepare and administer Aimovig using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique. Both presentations contain dry natural rubber (needle shield within white cap of prefilled autoinjector; gray needle cap of prefilled syringe), which may cause allergic reactions in patients sensitive to latex.

The list price of Aimovig is $575/month or $6,900/year, this is the same regardless of dose (70mg or 140mg).

For more information call (800) 772-6436 or visit Aimovig.com.