FDA approves Lundbeck's intravenous migraine prevention drug Vyepti, to launch in April 2020

Deerfield: Lundbeck announced that VYEPTI™ (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (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 a reduction in migraine days of at least 75 per cent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients"

Dr Deborah Dunsire, President and CEO of Lundbeck, commented "With the approval of VYEPTI, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The VYEPTI clinical program is the first to demonstrate this early benefit."

The efficacy and safety of VYEPTI were demonstrated in two phases 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 per cent and at least 2 per cent 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 per cent of patients treated with VYEPTI discontinued treatment due to adverse reactions.

"The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75 per cent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients," said Dr Peter Goadsby, a professor of neurology at King's College, London and the University of California, San Francisco. "VYEPTI is a valuable addition to the treatment of migraine, which can help reduce the burden of this serious disease."

The efficacy of VYEPTI™ (eptinezumab-jjmr) was evaluated as a preventive treatment of episodic and chronic migraine in two randomized, placebo-controlled studies, both with 6-month double-blind periods: one study in episodic (PROMISE-1; defined as 4-14 headache days per month, of which at least 4 were migraine days) and one study in patients with chronic migraine (PROMISE-2; defined as 15-26 headache days per month, of which at least 8 were migraine days). In both studies, patients were randomized to receive placebo, VYEPTI 100 mg, or VYEPTI 300 mg.

The primary endpoint was the change from baseline in mean MMD over months 1-3. Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (i.e., triptans, ergotamine derivatives), during the trial. Both studies excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, and cerebrovascular disease. In PROMISE-2, the study population included patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute-medication overuse of triptans, ergotamine, or combination analgesics greater than 10 days per month.

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