The United States Food and Drug Administration (US FDA) has just approved Vyepti™ for the preventive treatment of migraine. Vyepti (eptinezumab-jjmr) will be the first intravenous (IV) preventive treatment on the market for migraine disease. It will be available starting in April 2020 and is for adults with migraine. Most people taking Vyepti will receive 100 mg every 3 months, however, the dosage can be increased to 300 mg if needed.
How does Vyepti work?
Vyepti belongs to a class of drugs called human monoclonal antibodies. It is made from living cells that target very specific pathways in the body. Vyepti binds to a protein in the body called calcitonin gene-related peptide (CGRP). When Vyepti targets CGRP, it prevents it from taking action in the body. CGRP is found in the brain and sensory nerves of the head and neck. These nerves are part of the trigeminal system. CGRP can impact pain signaling in these pathways, leading to migraine pain. By blocking the action of CGRP, it may be possible to reduce pain and migraine symptoms.
Vyepti in clinical trials
The FDA’s approval of Vyepti was based on the results from 2 clinical trials. These trials were called PROMISE-1 and PROMISE-2. People with episodic migraine (4-14 headache days a month) were enrolled in the PROMISE-1 study, and people with chronic migraine (15-26 headache days per month) were enrolled in the PROMISE-2 study. Over 1,700 people took part in the trials.
In both trials, participants were given either 100 mg of Vyepti, 300 mg of Vyepti, or a placebo. Overall, the clinical trial’s primary endpoint was met since Vyepti was found to decrease average monthly migraine days over the first 1-3 months of use. This pattern continued through the second dose (6 months later).
Of those with chronic migraine, about 58 percent of people taking 100 mg of Vyepti had a 50 percent reduction in the average migraine days per month over the first 3 months. Additionally, 61 percent of those taking 300 mg experienced the same. Some participants experienced benefits of treatment quite quickly, with relief beginning within the first 1 to 7 days after infusion.