14 September 2018 - Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. 

Ajovy a humanized monoclonal antibody that binds to calcitonin gene-related peptide ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.

Ajovy was evaluated in two Phase III, placebo-controlled clinical trials that enrolled patients with disabling migraine and was studied as both a stand-alone preventive treatment and in combination with oral preventive treatments. In these trials, patients experienced a reduction in monthly migraine days during a 12-week period. The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

The U.S. wholesale acquisition cost of Ajovy is $575 per monthly dose and $1,725 per quarterly dose. Ajovy will be available through retail and specialty pharmacies in approximately two weeks.

Read Teva Pharmaceuticals press release