The US Food and Drug Administration (FDA) has granted approval to Israel-based Teva Pharmaceutical Industries for its AJOVY (fremanezumab-vfrm) injection intended for the preventive treatment of migraine in adults, it was reported yesterday.

The a humanised 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.

The product was assessed 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 decrease in monthly migraine days during a 12-week period. The most common adverse reactions (less than 5% and greater than placebo) were injection site reactions.

The U.S. Wholesale Acquisition Cost (WAC) of AJOVY is USD575 per monthly dose and USD1,725 per quarterly dose. AJOVY will be available through retail and specialty pharmacies in approximately two weeks.