FDA Approves Ajovy
FDA Approves Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine
September 14, 2018 -- Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy 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. Aimovig (erenumab-aooe), the first in this class, was approved on May 17, 2018.
Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Migraine attacks can cause significant pain or hours to days and can be so severe that the pain is disabling. 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.
Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity reactions, including rash, pruritis (itching), drug hypersensitivity, and urticaria (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. The most common adverse reactions were injection site reactions and infections.
Posted: September 2018
- Teva Confirms September PDUFA Date for Fremanezumab - May 23, 2018
- FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program - December 18, 2017
- Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA - October 17, 2017
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