CHMP recommends Vyepti for the preventive treatment of migraine.
Subject to final approval by the European Commission, Vyepti will be the first and only approved IV treatment for migraine prevention in EU. CHMP based its positive opinion on the efficacy and safety of Vyepti, which has been demonstrated 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 observed for both doses of Vyepti as early as day 1 post-infusion, and a sustained effect on patient-relevant outcomes was observed for up to 96 weeks.
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 ( greater than 2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with Vyepti discontinued treatment due to adverse reactions.
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