The approval follows the positive opinion on
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 (
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