On September 27, 2018, the U.S. Food and Drug Administration (FDA) approved galcanezumab-gnlm (Emgality) for the preventive treatment of migraine in adults. Emgality is the third antibody therapeutic approved by FDA in 2018 for this indication. As we reported in previous posts, Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018. The three products target either calcitonin gene-related peptide (CGRP) or the CGRP receptor. The recommended dosage of Emgality is 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg.
The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1, EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. In EVOLVE-1, the mean change from baseline (days) was -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001), while in EVOLVE-2, the mean change from baseline (days)was -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001). In the REGAIN study, the mean change from baseline (days) was -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001).
The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 28, a total of 10 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 6 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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