FDA Approves New Migraine Prevention Drug, Ajovy

On Friday, the U.S. Food and Drug Administration (FDA) approved a new drug designed to prevent migraine attacks in adults.

The drug, called Ajovy, works by blocking the activity of the calcitonin gene-related peptide (CGRP). CGRP is a neurotransmitter found in increased amounts in the blood during a migraine. It is believed to play a role in migraine because it encourages the release of pro-inflammatory chemicals and creates an inflammation feedback loop as it releases over the course of four to 72 hours, the typical length of a migraine. The new drug uses antibodies to block the receptor on the cell surface that CGRP needs to bind to in order to work.

Ajovy is not the first anti-CGRP migraine prevention drug, as the drug Aimovig received FDA approval in May. However, Ajovy is unique in that it can be administered via monthly or quarterly injections, whereas Aimovig currently only offers monthly injections.

Teva Pharmaceuticals, the company manufacturing the drug, said Ajovy will be available in U.S. pharmacies within about two weeks for $575 per monthly dose and $1,725 per quarterly dose. The cost is identical to that of Aimovig, which is available for $6,900 a year or $575 monthly. It’s unclear how much of this would be covered by insurance.

Two clinical trials evaluated the effectiveness of the drug. The first study was double-blind and included adults with a history of episodic migraine (patients with less than 15 headache days per month). Patients randomly received either a quarterly dosage, three monthly dosages or a placebo over the course of three months. Prior to the study, the 875 patients experienced an average number of nine migraine days per month. At the end of the three-month period, those who took the three monthly dosages had an average of 3.7 fewer migraine days per month, those who took the single quarterly dosage had an average of 3.4 fewer migraine days per month, and those who took the placebo had an average of 2.2 fewer migraine days per month.

The second study included adults with a history of chronic migraine (patients with 15 or more headache days per month). Again, patients received either a quarterly dosage, three monthly dosages or a placebo over a three-month period. The 1,034 patients who completed the study had an initial average of 20.3 migraine days per month. After the three months, this average dropped 4.6 days for those taking the quarterly dosage, 4.3 days for those taking the monthly dosage, and 2.5 days for those taking the placebo.

It is not yet clear if the drug has any long-term risks, though the most common side effect noted during the clinical trials was a reaction at the injection site.

Stephen Silberstein, MD, the lead investigator of the Phase III clinical trial program for Ajovy and director of the Jefferson Headache Center at Thomas Jefferson University Hospital, said, “About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

Competition among anti-CGRP migraine preventative drugs is expected to increase, with the FDA planning to make a decision about a similar new drug from Eli Lilly next month.