Lundbeck has received Fast Track designation from the US FDA for the company’s lead oral orexin 2 receptor agonist and a key investigational compound in its expanding sleep-wake disorder portfolio.
The designation marks a significant step forward in Lundbeck’s efforts to develop innovative therapies targeting neurological and sleep-wake disorders, while accelerating collaboration with regulators to advance promising treatment options for patients
Discovered by Lundbeck, Lu AH69593 is currently being evaluated in a Phase 1b clinical trial for the treatment of narcolepsy, a chronic neurological disorder that affects the brain’s ability to control sleep and wakefulness.
Narcolepsy can have a profound impact on everyday life, with symptoms including excessive daytime sleepiness, sudden sleep attacks, disrupted nighttime sleep, sleep paralysis and hallucinations.
People with narcolepsy type 1 may also experience cataplexy — a sudden loss of muscle tone often triggered by strong emotions — adding further challenges to education, work, social activities and overall quality of life.
The FDA’s Fast Track designation highlights the potential of Lu AH69593 to address a significant unmet need in narcolepsy treatment by targeting the orexin pathway, a critical biological system responsible for maintaining stable wakefulness and regulating the sleep-wake cycle.
Orexin is a wake-promoting neuropeptide produced in the lateral hypothalamus, with signals transmitted throughout the brain to regions involved in arousal, wakefulness and REM sleep regulation. The orexin 2 receptor (OX2R) plays a central role in promoting wakefulness, making it a highly relevant therapeutic target for disorders associated with excessive daytime sleepiness.
Designed to be a potential best-in-class OX2R agonist, Lu AH69593 aims to enhance orexin signaling and restore wakefulness and sleep-wake balance in people living with narcolepsy. While existing treatments can help manage symptoms, many patients continue to experience a substantial disease burden.
"Fast Track designation is an important milestone for Lu AH69593 and for our ambition to translate compelling orexin biology into a new treatment approach for narcolepsy and other sleep-wake disorders,” said Johan Luthman, Executive Vice President R&D, Lundbeck.
“For people living with narcolepsy, the ability to sustain wakefulness can shape almost every part of daily life. Fast Track designation underscores the urgent need for innovative therapies for narcolepsy and recognizes the potential of Lu AH69593.
"This program is a good example of Lundbeck’s transformation of the R&D pipeline into breakthrough neurology, neuroendocrine and rare indication programs, with potential for regulatory designations facilitating development. We are encouraged by the opportunity to work closely with the FDA as we advance Lu AH69593.”
