FDA Approves Drug for Migraine Prevention

Officials with the FDA have approved fremanezumab-vfrm (Ajovy, Teva) for the preventive treatment of migraine in adults.

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.

Two recommended subcutaneous dosing options of fremanezumab-vfrm are available to administer:

• 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.

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