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news.Lundbeck has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational treatment, Lu AH69593, to treat narcolepsy.
Narcolepsy is described as a chronic neurological condition that affects the brain’s regulation of sleep and wakefulness. Credit: Toa55 / Shutterstock.com.
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Lu AH69593 is an oral, small-molecule agonist of the orexin 2 receptor (OX2R). The compound is currently being studied in a Phase Ib clinical trial focused on patients with narcolepsy.
The designation aims to facilitate the development and accelerate the FDA review process for medicines that target serious conditions and fulfil unmet medical needs.
Lundbeck stated that this regulatory milestone advances its development portfolio relating to sleep-wake disorders.
Narcolepsy is described as a chronic neurological condition that affects the brain’s regulation of sleep and wakefulness.
Individuals with narcolepsy often deal with symptoms such as excessive daytime sleepiness, frequent sleep attacks, fragmented sleep during the night, sleep paralysis, and hallucinations.
Orexin-producing neurons in the lateral hypothalamus of the brain, play a central role in arousal, wakefulness, and rapid-eye-movement (REM) sleep regulation.
Orexin signals through two receptors: orexin 1 and orexin 2.
The OX2R is particularly linked to promoting wakefulness and regulating sleep-wake cycles, making it a relevant target in narcolepsy and similar disorders marked by excessive daytime sleepiness.
Discovered by Lundbeck, Lu AH69593 is designed to activate the OX2R with the aim of enhancing wake-promoting signalling. The compound is not approved for marketing anywhere and its safety and efficacy have not yet been established.
Lundbeck R&D executive vice-president Johan Luthman 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.
“This programme is a good example of Lundbeck’s transformation of the R&D pipeline into breakthrough neurology, neuroendocrine and rare indication programmes, with potential for regulatory designations facilitating development.”
The company will continue working with the FDA as the clinical development continues.
