Teva Pharmaceutical Industries Ltd has announced that the U.S. Food and Drug Administration (FDA) has approved AJOVY™ (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.
AJOVY, a humanised 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.
“Migraine is a disabling neurological disease that affects more than 36 million people in the United States”
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 percent and greater than placebo) were injection site reactions.
Stephen Silberstein, MD, Director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial program for AJOVY said, “Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with this condition may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”
Kåre Schultz, President and CEO of Teva said, “The approval of AJOVY helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders – patients, employees and shareholders.”
Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva said, “Today’s approval is an important step forward for Teva and the migraine community. Our entire organisation is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much needed category.”