Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

Core Viewpoint - Nxera Pharma has submitted a marketing authorisation application for daridorexant in South Korea, targeting the treatment of insomnia in adults, following successful Phase 3 trial results [1][9]. Group 1: Company Overview - Nxera Pharma is a biopharmaceutical company focused on developing specialty medicines for unmet medical needs, with operations in Japan, the UK, Switzerland, and South Korea [13]. - The company has a partnership with Shionogi for the commercialization of daridorexant in Japan, where it is marketed as QUVIVIQ® [3][13]. Group 2: Product Information - Daridorexant is a dual orexin receptor antagonist designed to treat insomnia by reducing overactive wake signals, and it has shown efficacy in improving subjective total sleep time, sleep onset latency, and wake after sleep onset in clinical trials [9][12]. - The Phase 3 trial demonstrated significant improvements in sleep metrics, with p-values less than 0.0001 for the primary and secondary endpoints compared to placebo [12]. Group 3: Market Context - Insomnia affects approximately 15-25% of the adult population in South Korea, translating to about 6.5-11 million individuals [2][7]. - The number of chronic insomnia patients treated in South Korea has increased by 21% from 2018 to 2022, indicating a growing market for insomnia treatments [7].