EC nod for Vyepti in migraine prevention

The European Commission has granted marketing authorization for Vyepti (eptinezumab) in the European Union for the prophylactic treatment of migraine in adults who have at least four migraine days per month.

The approval, granted to Danish CNS specialist Lundbeck (LUND: CO), follows the positive opinion on November 11, 2021 from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Vyepti is the first and only approved IV treatment for migraine prevention in the EU. The marketing authorization for Vyepti is an important step to increase Lundbeck’s global footprint, the company stated, and it is an important building block in the corporate strategy of Expand and Invest to Grow.

The marketing authorization is based on the efficacy and safety of Vyepti, which has been investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). The clinical trial program demonstrated a reduction in monthly migraine days over placebo, which was sustained for the 12-week dosing interval, and for the duration of treatment (12 months in PROMISE-1 and six months in PROMISE-2). A reduction in prevalence of migraine of about 50% was observed for both doses of Vyepti on day 1 post-infusion. Effects on patient-reported outcomes were observed for up to 96 weeks. Also, the efficacy of Vyepti in migraine was demonstrated in patients with a dual diagnosis of chronic migraine and medication overuse headache (MOH) from the PROMISE-2 study.