Biopharmaceutical company XW Laboratories Inc disclosed on Monday the receipt of US Food and Drug Administration (FDA) orphan drug designation for its lead proprietary compound XWL-008 for the treatment of patients with narcolepsy.
Narcolepsy is a chronic neurological sleep disorder in patients with abnormal regulation of their sleep-wake cycle. This disorder is typically characterised by excessive daytime sleepiness and cataplexy (sudden muscle weakness triggered by emotion), among other symptoms.
In conjunction, the company has recently reached a major milestone in XWL-008 development by successfully completing Phase 1 studies, yielding robust results demonstrating favourable safety, tolerability and pharmacokinetics. It is now preparing for late-stage phase 3 clinical research and a 505(b)(2) NDA regulatory pathway to bring this novel drug candidate to narcolepsy patients worldwide, said its founder and CEO Jia-Ning Xiang.
The US FDA Orphan Drug Designation programme reportedly grants orphan status to promising investigational drugs designed to treat, prevent, or diagnose rare medical diseases or conditions that affect fewer than 200,000 individuals in the US. Orphan designation qualifies sponsors for several key benefits and incentives, including tax credits for clinical testing, exemption from marketing application user fees, and seven-year marketing exclusivity upon FDA approval.
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