Lundbeck’s attempt to fast-track migraine drug Vyepti (eptinezumab) into China and Asia via the SUNLIGHT trial has failed to meet primary endpoints, according to the firm’s Q2 2022 financial report and subsequent earnings call. The drug, approved in the US in February 2020 and in Europe in January 2022, saw sales surge 100% to DKK 390 million (USD 53 million) in Q2 2022.
Trial Details
The SUNLIGHT trial (NCT04772742) aimed to accelerate Vyepti’s Asian approval by recruiting nearly 200 patients, mostly in China, focusing on migraine and medication overuse headache (MOH). However, the study did not achieve significant improvement in monthly migraine days, despite outperforming placebo. Lundbeck’s R&D head Per Luthman cited a stronger-than-expected placebo effect and the trial’s small size as factors impacting statistical results.
Strategic Shift
Development will now rely on the larger SUNRISE trial (NCT04921384), a multi-regional study with over 500 patients across six countries, expected to complete enrollment by February 2023. Lundbeck remains committed to globalizing Vyepti, emphasizing its rapid efficacy in reducing migraine days post-infusion.-Fineline Info & Tech
