Vyepti™ (eptinezumab-jjmr; Lundbeck) is now available for the preventive treatment of migraine in adults through select specialty distributors and pharmacies.
Vyepti is a calcitonin gene-related peptide (CGRP) inhibitor that is administered by intravenous infusion over approximately 30 minutes once every 3 months. The product is supplied as 100mg/mL of eptinezumab-jjmr in single-dose vials. Vyepti does require dilution prior to administration.
The approval was based on data from two phase 3, placebo-controlled trials, PROMISE 1 (N=665) and PROMISE 2 (N=1072), which evaluated the efficacy and safety of Vyepti in adults as a preventive treatment of episodic and chronic migraine, respectively. Findings from both trials showed that Vyepti (100mg and 300mg) was associated with a significantly greater mean change from baseline in mean monthly migraine days (MMD) compared with placebo over months 1-3.
In both studies, treatment benefit over placebo was observed as early as day 1 post-infusion. Moreover, compared with Vyepti-treated patients, a greater percentage of those who received placebo had migraines on individual days during the first 7 days of the treatment period.
Regarding safety, the most common adverse reactions reported included nasopharyngitis and hypersensitivity. In clinical trials, most hypersensitivity reactions (ie, angioedema, urticaria, facial flushing, rash) occurred during infusion and were not serious, but often led to discontinuation or required treatment.
In addition, as with other therapeutic proteins, there is a potential for development of anti-eptinezumab-jjmr antibodies, including neutralizing antibodies. Results from both clinical trials showed no clear evidence of an impact on safety or efficacy, however definitive conclusions could not be drawn due to limited data.
“We are pleased to announce the availability of Vyepti for migraine prevention in the US, along with a suite of online resources for patients and their healthcare providers, which we hope will be useful to learn more about this new treatment option,” said Peter Anastasiou, Lundbeck’s EVP, North America. “While we recognize and face the challenges of this global pandemic together, Lundbeck remains steadfast in our commitment to bring Vyepti to patients.”