Fremanezumab-vfrm Approved for Prevention of Migraine
The Food and Drug Administration (FDA) has approved fremanezumab-vfrm (Ajovy; Teva Pharmaceutical Industries, Jerusalem, Israel) for prevention of migraine in adults. Fremanezumab is administered as a subcutaneous injection by the patient or a health care professional and can be prescribed as a monthly dose in which a single injection (225 mg) is given each month or as a quarterly dose (675 mg) in which 3 consecutive injections are given every 3 months.
Fremanezumab is expected to be available in approximately 2 weeks through retail and specialty pharmacies. The price is set at $575 per monthly dose and $1,725 per quarterly dose. Through a savings offer for insured patients, some may be responsible for as little as $0 per dose until the offer expires. Support services are also available for patients who have difficulty paying for the drug. More information is available at ajovy.com.
Fremanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand to block binding to the CGRP receptor. Approval was based on data from 2 phase 3 clinical trials that showed treatment with fremanezumab significantly reduced patients’ number of migraine days/month compared to placebo (P < .001) and increased the number of patients who had a 50% or more reduction in headache days/ month compared to placebo (P < .001). Treatment with fremanzumab also significantly reduced the number of days per month patients need acute (abortive) headache treatment and reduced disability as measured by the migraine disability assessment score (MIDAS).
Stephen Silberstein, MD, Director, Jefferson Headache Center at Thomas Jefferson University Hospital, lead investigator of the phase 3 clinical trial program for fremanezumab, and a member of the Practical Neurology editorial board 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.”