Regulatory Decision Summary for Vyepti

Migraine is the most prevalent neurological disease for which medical treatment is sought; it is one of the leading causes of disability worldwide and the leading cause in both men and women aged 15-49 years.

Three calcitonin gene-related peptide (CGRP)-antagonists have received approvals for the prevention of migraine. Vyepti (eptinezumab) is the fourth in this class.

The efficacy and safety of Vyepti were evaluated in two phase 3, randomized, double-blind, placebo-controlled trials in adults with episodic and chronic migraines.

In episodic migraine study, the first dose of Vyepti 100 mg and 300 mg reduced the monthly migraine days from baseline by a mean of 3.9 days and 4.3 days compared to placebo (a reduction of 3.2 days). The differences vs. placebo (0.7 days and 1.1 days, respectively) were statistically significant.

In the chronic migraine study, the first dose of Vyepti 100 mg and 300 mg reduced the monthly migraine days from baseline by a mean of 7.7 and 8.2 days, respectively, by Week 12 compared to a mean reduction of 5.6 days in the placebo group. The differences compared to placebo of an additional 2.0 and 2.6 days, respectively were statistically significant. This result was supported by key secondary endpoints.

The most common adverse events were nasopharyngitis and the most commonly reported drug-related adverse events were hypersensitivity including angioedema, swelling of face and lips and rash occurring at 2.6% and 3.8% in Vypeti 100 mg and 300 mg groups, respectively.

Vyepti has not been tested in geriatrics, pediatrics, pregnant and breastfeeding patients as well as patients with concomitant disorders such as diabetes, cardiovascular, neurological and autoimmune disorders. These limitations are described in the labelling.

The overall benefit/risk profile is considered acceptable for Vyepti when used for the prevention of migraine in adults who experience at least 4 migraine days per month.