FDA approves drug treatment to prevent migraines



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FDA officials have approved fremanezumab-vfrm (Ajovy, Teva) for the preventive treatment of migraine in adults.1

Fremanezumab-vfrm is the second FDA-approved migraine-preventative treatment in a new class of drugs that work by blocking the activity of the calcitonin gene-related peptide (CGRP), a molecule involved in migraine attacks. The first of this class, erenumab-aooe (Aimovig) was approved in May.1

Two recommended subcutaneous dosing options of fremanezumab-vfrm are available for administration:2 persons

  • 225 mg per month, or
  • 675 mg every 3 months (quarterly), administered in 3 consecutive subcutaneous injections of 225 mg each.

Ajovy is contraindicated in patients with severe hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity reactions, including rash, itching, drug hypersensitivity and hives, have been reported in clinical trials with Ajovy. Most of the reactions were mild to moderate, but some led to discontinuation of treatment or required treatment with corticosteroids. Most reactions have been reported between a few hours and a month after administration.1

The most common adverse reactions were injection site reactions and infections.1

Migraine pain is often described by patients as intense or throbbing pain in an 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 or days and can be so severe that the pain is disabling.1

The warning symptoms known as aura may appear before or with the headache. These may include flashes of light, blind spots or tingling on one side of your face or arm or leg.1

Reference

  1. FDA Approves New Drug for Preventative Treatment of Migraines in Adults-Drug Update Update. Drug Information Division of the FDA. Accessed September 14, 2018.
  2. Ajovy (fremanezumab-vfrm): Complete prescribing information. FDA. http://www.pharmacytimes.com/link/219. Accessed September 14, 2018.
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