FDA approves Ajovy for preventative treatment of migraine.- Teva
Teva Pharmaceutical Industries Ltd. announced that the 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 (CGRP) 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 (greater than 5 percent and greater than placebo) were injection site reactions.
Comment: Currently, generic triptans capture about 90% of the acute migraine market in the US. marketing survey data indicates that 75% of patients face cardiovascular risks related to triptan therapy and 30%-40% of patients taking triptans for migraine are non-responders.
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