Amid growing competition within the CGRP inhibitor class of migraine drugs, Lundbeck’s Vyepti has hit a setback in its market expansion plan.
Vyepti failed to significantly outdo placebo at reducing monthly migraine days in a phase 3 trial called Sunlight, Lundbeck disclosed (PDF) Wednesday alongside its second-quarter financial results.
The migraine prevention trial was conducted mostly in China and enrolled patients with a combined diagnosis of chronic migraine and medication overuse headache. The study was originally designed as an “accelerated path” to launch in China, Lundbeck said. But now, the company is forced to rely on another trial coded Sunrise, going back to its “base strategy” for a regulatory pathway across Asia, which also includes China, Johan Luthman, Ph.D., Lundbeck’s head of R&D, said during its earnings call Wednesday.
“We built a very aggressive trial for exploring what is possible for China,” Luthman said.
Luthman attributed the flop to the trial’s relatively small size of 182 patients and an unexpectedly strong performance from the placebo group. Occasional high placebo responses are not completely unexpected in pain trials, he added. Vyepti showed a numeric advantage over placebo in Sunlight but failed to meet statistical significance.
The Sunrise trial is much bigger, with a target enrollment of 513 chronic migraine patients but not requiring simultaneous diagnosis of medication overuse headache. Lundbeck plans to use it for approvals in China, Japan and Korea. The trial is enrolling well despite COVID-related challenges in China, Luthman said, adding that the timeline could be hard to predict because randomization is based on headache events.
Separately, Lundbeck unveiled a phase 4 trial called Resolution. Similar to the failed Sunlight study, Resolution will evaluate Vyepti as a migraine preventive in patients with both migraine and medication overuse headache. But the new trial aims to recruit around 570 patients.
Vyepti’s latest hiccup comes as competition among CGRP migraine drugs intensifies. Besides self-administered injectables such as Amgen’s Aimovig and Eli Lilly’s Emgality, newer orals like Biohaven’s—soon to be Pfizer’s thanks to a proposed $11.6 billion acquisition—Nurtec ODT and AbbVie’s Qulipta are quickly gaining market shares.
Vyepti is different in that it’s an infusion, and Lundbeck is counting on its fast onset of action to attract patients with more severe migraine. Approved by the FDA in February 2020, Vyepti sales jumped 120% year-over-year in the first half of 2022, reaching DKK 390 million ($53 million), including DKK 220 million in the second quarter.
Yet, that sales figure is no comparison to Nurtec’s $194 million for the second quarter alone. Nonetheless, Lundbeck CEO Deborah Dunsire lauded Vyepti as an “increasing contributor to growth” for the Danish company.
In the U.S. migraine prevention market, Vyepti has reached 4.7% market share, and the number of patients receiving repeated doses is also on the rise, Dunsire said on Wednesday’s call.
Vyepti also got its European Commission go-ahead in January. Lundbeck recently launched the drug in Australia, Singapore and Switzerland and expects additional rollouts in eight markets this year.
Overall, Lundbeck’s second-quarter sales reached DKK 4.48 billion, up 13.8% year over year. A group of “strategic brands,” which includes Vyepti, antidepressant Brintellix and antipsychotics Rexulti and Abilify, together contributed 66% of the revenue.