On September 14, 2018, the U.S. Food and Drug Administration (FDA) approved fremanezumab-vfrm (Ajovy) for the preventive treatment of migraine in adults. The drug may be administered as either 225 mg monthly, or 675 mg quarterly, subcutaneous doses. Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), thereby blocking the binding of the ligand to its receptor. The monoclonal antibody erenumab-aooe (Aimovig), which was approved by the FDA in May 2018 for the preventive treatment of migraine in adults, targets CGRP receptor, rather than the ligand. Marketing applications for galcanezumab, another monoclonal antibody that targets CGRP, are undergoing review by FDA and the European Medicines Agency.
The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of September 14, a total of 9 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 7 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.
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