The US Food and Drug Administration (FDA) has granted approval to Teva Pharmaceutical Industries’ Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.
Ajovy is a humanised monoclonal antibody designed to block the binding of calcitonin gene-related peptide (CGRP) ligand to the receptor.
The medicine is said to be the only anti-CGRP preventive therapy for migraine, and is available in a prefilled syringe with quarterly (675mg) and monthly (225mg) dosing options.
Teva president and CEO Kåre Schultz said: “This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system.
“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.”
Teva executive vice president of global research and development Hafrun Fridriksdottir said: “With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients.
“This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”
The FDA reviewed data on Ajovy obtained during two placebo-controlled Phase III clinical trials in patients with disabling migraine. The drug was evaluated as a monotherapy as well as in conjunction with oral preventive treatments.
The study showed a decrease in monthly migraine days during a 12-week treatment period with Ajovy. The most common adverse reactions during the trials were observed to be injection site reactions.
Ajovy Phase III clinical trial programme lead investigator Stephen Silberstein 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.”
Teva plans to launch Ajovy at retail and specialty pharmacies in about two weeks. The company also intends to partner with insurers to offer complete access and availability of the drug.