FDA approves Vyepti for migraine prevention.- Lundbeck

Lundbeck has announced that Vyepti (eptinezumab-jjmr) has been approved by the FDA for the preventive treatment of migraine in adults and will be available in April 2020. The recommended dose is 100 mg every 3 months; some patients may benefit from a dose of 300 mg. Vyepti is the first FDA-approved intravenous (IV) treatment for migraine prevention. “The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patient. The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). 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, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days. The safety of Vyepti was evaluated in 2,076 patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (?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..