On November 11, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in Amsterdam issued a positive opinion recommending the granting of a marketing authorisation for the medicinal product Vyepti for migraine prophylaxis. The applicant for this medicinal product is H. Lundbeck A/S. Vyepti will be available as a 100 mg concentrate for solution for infusion. The active ingredient in Vyepti is eptinezumab, a humanised monoclonal antibody, a migraine prophylactic (ATC code: N02CD05) that works by preventing the activation of CGRP receptors.

The benefit of Vyepti is a reduction in the number of monthly migraine days. The most common side effects are nasopharyngitis and hypersensitivity. The full indication is: Vyepti is indicated for the prophylaxis of migraine in adults who experience at least 4 migraine days per month.

Vyepti should be prescribed by doctors who have experience in treating migraines.

Detailed recommendations on the use of this medicinal product are described in the Summary of Product Characteristics (SmPC), which is published in the European Public Assessment Report (EPAR) and is available in all official languages ​​of the European Union after the European Commission has granted marketing authorisation.

Eptinezumab binds to the calcitonin gene-related peptide (CGRP). The drug prevents CGRP from binding to its receptor, thereby preventing migraine attacks. Vyepti is the first migraine-preventive antibody administered intravenously. The advantage is the rapid achievement of therapeutic drug levels in the blood. Effectiveness can thus begin as early as the day of the infusion. The infusion takes place within 30 minutes and is administered every 12 weeks. This allows migraine patients to receive preventive therapy with four treatments per year.

The efficacy, tolerability, and safety of Vyepti were demonstrated in two Phase III clinical trials: PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine. Significant effects were achieved for the primary endpoint of reduction in mean monthly migraine days (MMD) over weeks 1 to 12 in both episodic and chronic migraine. The mean reduction in MMD was approximately 4 migraine days per month in episodic migraine and approximately 8 days per month in chronic migraine. Efficacy compared to placebo was observed for both Vyepti doses as early as the first day after infusion. The safety of Vyepti was evaluated in 2,076 adult patients. The most common adverse reactions (≥2% and at least 2% or more than placebo) were nasopharyngitis and hypersensitivity. 1.9% of patients treated with Vyepti discontinued treatment due to side effects.

Source: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vyepti