DENMARK – The European Commission has granted marketing authorization of Lundbeck’s anti-Calcitonin Gene Related Protein (Anti-CGRP) antibody Vyepti (eptinezumab) in the European Union (EU) for the prophylactic treatment of migraine in adults who have at least four migraine days per month.

Vyepti is the first and only approved intravenous treatment for migraine prevention in the EU, according to the company, and it expects to launch the drug in the first European countries in the coming months.

The approval comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a favorable opinion in November.

The application was based on data from the PROMISE 1 and PROMISE 2 Phase III studies, which involved patients with episodic and chronic migraine, respectively.

According to Lundbeck, Vyepti was associated with fewer monthly migraine days than placebo, with the benefit lasting for the duration of treatment, which was 12 months in PROMISE-1 and six months in PROMISE-2.

Furthermore, the company reported a roughly 50% reduction in migraine prevalence for both Vyepti doses on day one post-infusion, with effects on patient-reported outcomes lasting up to 96 weeks.

It was also noted that PROMISE-2 data showed Vyepti to be beneficial in patients with a dual diagnosis of chronic migraine and medication overuse headache.

Lundbeck acquired Vyepti in 2019 as part of its acquisition of Alder BioPharmaceuticals in a deal worth nearly US$2 billion.

The transaction included a contingent value right (CVR) worth up to US$2 per share that was tied to European drug approval, a condition that has now been met.

As a result, Lundbeck stated that it owes approximately US$230 million to CVR holders, which it expects to pay in the coming weeks.

In February 2020, the FDA approved Vyepti for the prevention of migraines in adults. The drug is also approved in Australia, Canada, Kuwait, Singapore, Switzerland, and the United Arab Emirates, and Lundbeck says it is being considered in a number of other countries.

“We have high expectations [for] Vyepti, and with the EU approval, we look forward to providing a much-needed treatment option to millions of patients,” said Johan Luthman, head of R&D at the Danish drugmaker.

Following its April 2020 launch in the United States, sales of the treatment increased by more than 400 percent in the third quarter of last year to DKK 151 million (US$23 million).

AbbVie Inc (ABBV.N) said on Tuesday that the US Food and Drug Administration approved its once-daily oral medicine for the prevention of migraine in adults, adding a third drug to the drugmaker’s arsenal of treatments for severe headaches.

The drug, Vyepti, will compete with other migraine prevention drugs including Abbvie’s Qulipta, Eli Lilly’s Emgality, Amgen Inc’s Aimovig, and Biohaven Pharmaceutical Holding Co Ltd’s Nurtec ODT.

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