The European Commission has granted marketing authorization for Vyepti in the European Union for the prophylactic treatment of migraine in adults who have at least four migraine days per month.
The approval follows the positive opinion on November 11th, 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, and it is an important building block in the corporate strategy of Expand and Invest to Grow, it states.
Two phase III trials
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 6 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.
The safety of Vyepti was evaluated in approximately 2,000 patients with migraine who received at least one dose of Vyepti. The most common adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Most hypersensitivity reactions occurred during infusion and were not serious. Infusion site related adverse events occurred infrequently and in similar proportions of Vyepti and placebo patients (<2%) with no apparent relationship to Vyepti dose.
Launched on the US market
“We have high expectations to Vyepti and with the EU approval, we look forward to providing a much-needed treatment option to millions of patients and provide the possibility of reducing the medical and personal burden of migraine which otherwise immensely impair the family, social, and work life of these patients,” says Johan Luthman, EVP and Head of Research & Development in Lundbeck.
Vyepti was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020 and it is launched on the U.S. market. In addition, Vyepti has been approved in Australia, Canada, Kuwait, Singapore, Switzerland, United Arab Emirates, and is currently under review in several countries around the world.
Photo of Johan Luthman: Lundbeck