The FDA has approved eptinezumab (Vyepti; Lundbeck) for the prevention of migraine in adults. The drug, which is the first-ever intravenous migraine prophylactic, will become available for prescription in April 2020, Lundbeck said, with a recommended dose of 100 mg quarterly.
The agency’s decision was supported by data from a set of 2 phase 3 clinical trials—PROMISE-1 and PROMISE-2, in episodic and chronic migraine, respectively—the findings of which suggested that the humanized monoclonal antibody was beneficial over placebo as early as 1-day post-infusion. Additionally, the therapy was well tolerated, with only 1.9% of patients treated in the PROMISE program discontinuing due to adverse events (AEs).
“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,” Deborah Dunsire, MD, president and CEO, Lundbeck, said in a statement. “The Vyepti clinical program is the first to demonstrate this early benefit.”
The anti-calcitonin gene-related peptide (CGRP) drug joins a growing field of migraine preventives in that class, including erenumab (Aimovig; Amgen), galcanezumab (Emgality; Eli Lilly ), and fremanezumab (Ajovy; Teva), all of which are delivered via injection.
In PROMISE-1, 665 patients were randomized to either 100 mg (n = 221) or 300 mg (n = 222) intravenous eptinezumab or placebo (n = 222) every 3 months for 1 year. Baseline migraine frequency was 8.6 migraine days per month, comparable between groups.
From months 1 through 3, the mean change in migraine days was -3.9 days (P = .018) and -4.3 days (P <.001) for the 100 mg and 300 mg doses, respectively, compared to -3.2 days for the placebo group. Over that same window of time, 49.8% of patients in the 100 mg group (P = .009) and 56.3% of patients in the 300 mg group (P <.001) experienced ≥50% reduction in migraine days compared to 37.4% of those in the placebo group.
A ≥75% reduction in migrain days in months 1 through 3 was reported by 22.2% of the 100 mg group, 29.7% of the 300 mg group (P <.001), and 16.2% of the placebo group.
Likewise, in PROMISE-2, the mean change in monthly migraine days from baseline (16.1) during months 1 through 3 was -7.7 days in the 100 mg (P <.001) and -8.2 days in the 300 mg (P <.001) groups compared with -5.6 days for placebo. All told, 57.6% of the 100 mg group (P <.001) and 61.4% of the 300 mg group (P <.001) experienced ≥50% reduction in migraine days compared to 39.3% of the placebo group.
PROMISE-2 results showed that a ≥75% reduction in migraine days in months 1 through 3 was reported by 26.7% and 33.1% of patients in the 100 mg (P <.001) and 300 mg (P <.001) groups compared with 15.0% of placebo patients. In both trials, a greater percentage of placebo-treated patients had migraine on each individual day during the first 7 days of treatment compared to eptinezumab-treated patients.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter J. Goadsby, MD, PhD, professor of neurology at King’s College London and University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
FDA Approves Lundbeck’s VYEPTI (eptinezumab-jjmr) – The First and Only Intravenous Preventive Treatment for Migraine [press release]. Deerfield, IL: Lundbeck; Published February 21, 2020. businesswire.com/news/home/20200221005507/en/FDA-Approves-Lundbeck’s-VYEPTI™-eptinezumab-jjmr-–-Intravenous. Accessed February 22, 2020.