FDA Approves Drug Treatment to Prevent Migraines
Officials with the FDA have approved fremanezumab-vfrm (Ajovy, Teva) for the preventive treatment of migraine in adults.
Officials with the FDA have approved fremanezumab-vfrm (Ajovy, Teva) for the preventive treatment of migraine in adults.1
Fremanezumab-vfrm is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. The first in this class, erenumab-aooe (Aimovig) was approved in May.1
Two recommended subcutaneous dosing options of fremanezumab-vfrm are available to administer:2
- 225 mg monthly, or
- 675 mg every 3 months (quarterly), which is administered as 3 consecutive subcutaneous injections of 225 mg each.
Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity reactions, including rash, itching, drug hypersensitivity, and hives were reported with Ajovy in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.1
The most common adverse reactions were injection site reactions and infections.1
Migraine headache pain is often described by patients as an intense pulsing or throbbing pain in 1 area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Migraine attacks can cause significant pain for hours to days, and can be so severe that the pain is disabling.1
Warning symptoms known as aura may occur before or with the headache. These can include flashes of light, blind spots, or tingling on one side of your face or in your arm or leg.1
- FDA approves new drug for preventive treatment of migraines in adults-Drug Information Update. FDA Division of Drug Information. Accessed September 14, 2018.
- Ajovy (fremanezumab-vfrm): Full Prescribing Information. FDA. http://www.pharmacytimes.com/link/219. Accessed September 14, 2018.