On May 17, 2018, the U.S. Food and Drug Administration approved erenumab-aooe (Aimovig) for the preventive treatment of migraine in adults. Erenumab is a human monoclonal antibody that targets calcitonin gene-related peptide (CGRP) receptor, thereby blocking the activity of CGRP, which is involved in migraine attacks. The treatment is given by once-monthly subcutaneous injections.
The approval was based on data from three clinical trials that compared erenuman-aooe to placebo. Over 2000 participants were included in the studies. In the first study (STRIVE, NCT02456740), which included 955 participants with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one to two fewer monthly migraine days than those on placebo over a 6 month period. In the second study (ARISE, NCT02483585), which included 577 patients with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one fewer migraine day per month than those on placebo over a 3 month period. The third study, which evaluated 667 patients with a history of chronic migraine, patients treated with erenumab-aooe experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo over a three month period.
The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of May 17, a total of 4 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 10 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, located in the Members Only section.