Ajovy Approved by FDA as Second CGRP Blocker for Migraine Prevention
Today, the U.S. Food and Drug Administration (FDA) approved Ajovy™ (fremanezumab-vfrm) for the prevention of migraine in adults. Ajovy is a CGRP blocker and is manufactured by Teva Pharmaceuticals. CGRP (calcitonin-gene-related peptide) is a novel target for migraine prevention. The first CGRP blocker, Aimovig™ (erenumab-aooe), was approved in May.
Ajovy is available in a pre-filled syringe that is given subcutaneously (under the skin). It may be administered by a healthcare professional, the patient, or a caregiver. Two dosing options are available: 225 mg given monthly or 675 mg given every 3 months (quarterly).1
Teva's initial release states that the wholesale price of Ajovy will be $575 for the monthly dose and $1,725 for the quarterly dosing. In addition, Teva states that the pre-filled syringes will be available in pharmacies in two weeks.
How does Ajovy work?
The CGRP protein is involved in the dilation of veins (vasodilation) and in the sensory nervous system, both of which are impacted by migraine.2
Ajovy is a monoclonal antibody. Similar to antibodies that are naturally created by the body to target specific invaders, monoclonal antibodies are created in a laboratory to attach to specific proteins. Ajovy attaches to the CGRP peptide ligand, and blocks its binding to the receptor.
Research has found that during a migraine attack, CGRP levels are increased. By blocking the protein’s ability to connect with the receptor, Ajovy may reduce the frequency or severity of migraine attacks.
How effective is Ajovy?
Ajovy was studied in randomized, double-blind, placebo-controlled studies. In the first study, a total of 791 patients who had a history of episodic migraine (less than 15 migraine days a month) were randomly assigned to receive one of three treatment arms: 675 mg of Ajovy given once every three months, 225 mg given monthly, or a placebo given monthly. Patients who received the quarterly injection had an average of 3.7 less migraine days per month, while the patients who received the monthly injection of Ajovy had an average of 3.4 less migraine days per month. (In comparison, those who received the placebo had 2.2 less migraine days per month.) Patients who received Ajovy also used less acute migraine treatment.1
The second study of Ajovy was conducted in 1,034 adults with chronic migraine (more than 15 days of migraine a month). Similar to the other study, patients were randomly assigned to receive one of three treatment arms: 675 mg of Ajovy given once every three months, 225 mg given monthly, or a placebo given monthly. Patients who received the quarterly injection had an average of 4.3 less migraine days per month, while the patients who received the monthly injection of Ajovy had an average of 4.6 less migraine days per month, compared to those who received the placebo who had 2.5 less migraine days per month.1
What are the possible side effects of Ajovy?
The most common side effects experienced by patients receiving Ajovy in clinical trials were injection site reactions, such as redness or pain at the site of the injection. In some people, Ajovy caused a hypersensitivity reaction (severe allergic reaction), which may appear as a rash, itching, or hives. If an allergic reaction occurs, contact your healthcare provider; they may consider discontinuing Ajovy and institute appropriate follow-up care.1
Why is this approval so important?
Prior to the discovery of CGRP blockers, treatments for migraine were often drugs used for other conditions, like medications for high blood pressure or epilepsy. Many of the treatments that have been available for migraine often have significant side effects that can make them intolerable.
Considering the debilitating effects of migraine, the new options of CGRP blockers are a welcome relief, offering hope for the millions of Americans who suffer from this severe and devasting condition. Ajovy is the first of the anti-CGRP drugs to offer people with migraine the option of receiving preventive treatment once a month or once every three months.
Other pharmaceutical companies are currently developing additional CGRP blockers and additional approvals are expected within the next year.
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