Posted from: Monday, October 08, 2018 - 12:42 PM - Present

Ajovy Approved to Treat Migraines

September 14, 2018 – The U.S. FDA has approved Ajovy™ (fremanezumab-vfrm), manufactured by Teva Pharmaceuticals, to prevent migraines in adult patients. It is the second in a new class of drugs, known as calcitonin gene-related peptide (CGRP) inhibitors, to receive FDA approval.

An estimated 36 million individuals in the United States suffer from migraines. According to a press release from Teva, as many as 40% of people who experience migraines go untreated. Symptoms include fatigue, irritability, difficulty speaking clearly, flashes of light or other visual disturbances, head pain, and nausea.

In May 2018, the FDA approved Novartis’s Aimovig® (erenumab-aooe), the first CGRP inhibitor available on the U.S. market. Unlike Aimovig, which requires a once-monthly injection under the recommended dosing, Ajovy offers both quarterly and monthly dosing options. Recommended dosing is one 225mg subcutaneous (SC) injection per month, or three consecutive 225mg (for a total dose of 675mg) SC injections every three months. Injections should be administered in the thigh, abdomen, or upper arm.

Teva Pharmaceuticals launched Ajovy shortly after approval at a wholesale acquisition cost (WAC) of $575 per month, or $1,725 per quarter. Some patients may be eligible for a savings offer from TEVA.

Last Updated Friday, October 19, 2018 - 06:41 PM.