Lundbeck announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lu AH69593, the company's lead oral orexin 2 receptor agonist and one of several investigational compounds in Lundbeck's development portfolio for sleep-wake disorders. Lu AH69593 was discovered by Lundbeck and it is presently in phase 1b development for the treatment of patients with narcolepsy.

Narcolepsy is a chronic neurological disorder that disrupts the brain's ability to regulate sleep and wakefulness. People living with narcolepsy may experience excessive daytime sleepiness, sudden sleep attacks, fragmented nighttime sleep, sleep paralysis and hallucinations. In narcolepsy type 1, symptoms also include cataplexy, a sudden loss of muscle tone often triggered by emotions. These symptoms can affect daily functioning, education, work, social life and quality of life.

Orexin is a wake-promoting neuropeptide that plays a key role in stabilizing sleep and wakefulness. Orexin-producing neurons are located in the lateral hypothalamus and project broadly across the brain to regions involved in arousal, wakefulness and REM sleep regulation. Orexin signals through the orexin 1 and orexin 2 receptors, of which the orexin 2 receptor, or OX2R, is considered central to wake-promoting signaling and sleep-wake regulation. Disruption of orexin signaling is therefore a highly relevant therapeutic target in narcolepsy and other disorders characterized by excessive daytime sleepiness.

Lu AH69593 is designed with the ambition of achieving a best-in-class compound to activate the OX2R and enhance wake-promoting signaling through the orexin pathway. By targeting a pathway directly linked to wakefulness biology, Lu AH69593 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 for many patients.

"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."

Fast Track designation is an FDA process designed to facilitate development and expedite review of medicines intended to treat serious conditions and address unmet medical needs.