Lundbeck has received Fast Track designation from the U.S. FDA for Lu AH69593, its lead oral orexin 2 receptor agonist in development for narcolepsy. The compound, discovered by Lundbeck, is in phase 1b studies.
Narcolepsy is a chronic neurological disorder that impairs the brain’s regulation of sleep and wakefulness.
Symptoms can include excessive daytime sleepiness, sudden sleep attacks, fragmented nighttime sleep, sleep paralysis and hallucinations. In narcolepsy type 1, cataplexy can also occur. These symptoms can affect daily functioning, education, work, social life and quality of life.
Orexin is a wake‑promoting neuropeptide central to stabilising sleep and wakefulness. Orexin‑producing neurons project widely across the brain to regions involved in arousal, wakefulness and REM sleep regulation.
Orexin signals through two receptors, of which the orexin 2 receptor is considered central to wake‑promoting signalling and sleep‑wake regulation. Disruption of orexin signalling is a relevant therapeutic target in narcolepsy and other disorders characterised by excessive daytime sleepiness.
Lu AH69593 is designed to activate the orexin 2 receptor and enhance wake‑promoting signalling through the orexin pathway.
By targeting a pathway directly linked to wakefulness biology, the compound is intended to restore wakefulness and sleep‑wake regulation in people living with narcolepsy, where current treatments can help manage symptoms but significant disease burden remains.
Johan Luthman, Executive Vice President R&D, Lundbeck, said: “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.
“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.”
He added: “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.”
Fast Track designation is an FDA process intended to facilitate development and expedite review of medicines for serious conditions and unmet medical needs.
