-
Vyepti is the first intravenous (IV) treatment approved for migraine prevention in
Europe - Vyepti is expected to be launched in the first European countries in the coming months
Valby,
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.
Dr.
"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."
The marketing authorization is valid in all EU Member States,
The formal approval means that the milestone for the Contingent Value Rights (CVRs) of
About Vyepti®
Vyepti is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of Vyepti 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where Vyepti met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion. The safety of Vyepti was evaluated in 2,076 adult patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment due to adverse reactions.
About Migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also impose both a social and financial burden, affecting close to 50 million people in
Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and worker productivity. In
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About
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences.
Our approximately 5,600 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in
For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.
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