CGRP: calcitonin gene-related peptide.
Study design: A phase 1 study evaluated the pharmacokinetic profile, safety, tolerability, and immunogenicity of the doses of AJOVY tested in the phase 2 and 3 trials (225 mg and 675 mg) following single administration in healthy subjects. Healthy subjects in this phase 1 study who were given a 225 mg dose had a mean concentration of 22.1 μg/mL at day 29 and those given 675 mg had a mean concentration of 24.1 μg/mL at day 85. These time points approximate the end of the monthly and quarterly dosing ranges, respectively.1
References: 1. Cohen-Barak O, Weiss S, Rasamoelisolo M, et al. A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018;38(13):1960-1971. 2. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA, Inc. 3. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc. 4. Silberstein SD, Edvinsson L. Is CGRP a marker for chronic migraine? Neurology. 2013;81(14):1184-1185. 5. Bigal ME, Walter S, Rapoport AM. Calcitonin gene-related peptide (CGRP) and migraine current understanding and state of development. Headache. 2013;53(8):1230-1244. 6. Bigal ME, Walter S, Rapoport AM. Therapeutic antibodies against CGRP or its receptor. Br J Clin Pharmacol. 2015;79(6):886-895.