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Teva's Ajovy for migraine gets FDA green light

Teva Pharmaceutical Industries has received clearance from the Food and Drug Administration for Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,”Stephen Silberstein, Jefferson Headache Center director at Thomas Jefferson University Hospital and lead investigator of Phase III clinical trial program at Ajovy, said. “About 40% of people living with migraine 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.”

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, according to the company.

“This is an important day for Teva, and complements our long-standing history of helping patients living with diseases of the central nervous system,” Teva president and CEO Kare Schultz 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.”

“With limited availability of preventive treatment options, Ajovy provides physicians with an important new option for their patients,” Teva executive vice president, global R&D Hafrun Fridriksdottir said. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”

“Today’s approval is an important step forward for Teva and the migraine community,” Teva executive vice president and head of North America Commercial Brendan O’Grady said.“Our entire organization 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.”
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