The U.S. FDA has awarded Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for treating patients with narcolepsy
The orexin 2 receptor sits at a key point in the main biological pathway that controls wakefulness and sleep-wake cycles
Lu AH69593 is now in Phase 1b trials for patients with narcolepsy
The designation represents a key regulatory step as Lundbeck moves forward with its collection of programs for individuals with sleep-wake disorders

Lundbeck announced today that the U.S. Food and Drug Administration has awarded Fast Track designation to Lu AH69593, the firm's primary oral orexin 2 receptor agonist and one of several investigational agents in Lundbeck's development portfolio for sleep-wake disorders. Lu AH69593 was discovered internally by Lundbeck and is currently in phase 1b development for the treatment of patients with narcolepsy.

Narcolepsy is a long-term neurological condition that interferes with the brain's control of sleep and wake states. Individuals with narcolepsy can face excessive daytime sleepiness, abrupt sleep episodes, broken nighttime rest, sleep paralysis and hallucinations. In narcolepsy type 1, symptoms also feature cataplexy, a sudden drop in muscle tone often set off by strong emotions. These issues can influence daily activities, schooling, employment, social interactions and overall quality of life.

Orexin is a neuropeptide that promotes wakefulness and helps stabilize the balance between sleep and alertness. Orexin-producing neurons reside in the lateral hypothalamus and send projections throughout the brain to areas tied to arousal, wakefulness and REM sleep control. Orexin acts via the orexin 1 and orexin 2 receptors, with the orexin 2 receptor viewed as central to wake-promoting signals and sleep-wake balance. Interference with orexin signaling therefore stands as a highly pertinent therapeutic focus in narcolepsy and other conditions marked by excessive daytime sleepiness.

Lu AH69593 is built with the goal of delivering a best-in-class molecule that activates the OX2R and boosts wake-promoting signals along the orexin route. By engaging a pathway closely connected to wakefulness biology, Lu AH69593 aims to restore wakefulness and sleep-wake balance in people living with narcolepsy, where existing therapies can ease symptoms yet many patients still carry a notable disease burden.

"Fast Track designation marks an important step for Lu AH69593 and for our goal of turning strong orexin science into a fresh treatment option for narcolepsy and other sleep-wake disorders," said Johan Luthman, Executive Vice President R&D, Lundbeck. "For people living with narcolepsy, the capacity to maintain wakefulness can influence nearly every aspect of daily life. Fast Track designation highlights the pressing need for new therapies for narcolepsy and acknowledges the promise of Lu AH69593. This program illustrates Lundbeck's shift of the R&D pipeline toward breakthrough neurology, neuroendocrine and rare indication efforts, with potential for regulatory pathways that speed development. We are pleased by the chance to collaborate closely with the FDA as we progress Lu AH69593."

Fast Track designation is an FDA pathway created to speed development and review of medicines aimed at serious conditions and unmet medical needs.

About Lu AH69593

Lu AH69593 is an investigational small-molecule orexin 2 receptor agonist under development by Lundbeck for narcolepsy. Orexin, also called hypocretin, is a neuropeptide involved in arousal, wakefulness and sleep-wake stability. Lu AH69593 is designed with the goal of achieving a best-in-class compound to activate OX2R, a receptor central to wake-promoting orexin signaling. Lu AH69593 is currently under evaluation in a Phase 1b clinical program, with Lundbeck continuing to examine its safety, tolerability, pharmacokinetic and pharmacodynamic profile.

Lu AH69593 remains an investigational compound that is not approved for marketing by any regulatory authority worldwide, and the efficacy and safety of Lu AH69593 have not been established.

About narcolepsy

Narcolepsy is a chronic neurological sleep-wake disorder marked by excessive daytime sleepiness and impaired regulation of sleep and wakefulness. Symptoms may include sleep attacks, fragmented nighttime sleep, sleep paralysis, hallucinations and, in narcolepsy type 1, cataplexy. In narcolepsy type 1, low levels of hypocretin, also known as orexin, represent a central biological trait. Current treatments can help manage symptoms, but many people living with narcolepsy continue to experience meaningful effects on daily functioning, education, work and quality of life.

Contacts

Anders Crillesen	Jens Høyer
Senior Director, External and Internal Relations	Vice President, Head of Investor Relations
[email protected]	[email protected]
+45 27 79 12 86	+45 30 83 45 01

About H. Lundbeck A/S

Lundbeck is a biopharmaceutical company focused solely on brain health. With more than 70 years of experience in neuroscience, we are dedicated to improving the lives of people with neurological and psychiatric diseases.

Brain disorders affect a large portion of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.

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Bassetti CLA, Adamantidis A, Burdakov D, et al. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019;15:519–539.
Kornum BR, Knudsen S, Ollila HM, et al. Narcolepsy. Nat Rev Dis Primers. 2017;3:16100.
Black J, Reaven NL, Funk SE, et al. The Burden of Narcolepsy Disease (BOND) study: health-care utilization and cost findings. Sleep Medicine. 2014;15: 522–529.
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Sakurai T. The neural circuit of orexin/hypocretin: maintaining sleep and wakefulness. Nat Rev Neurosci. 2007;8:171–181.
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U.S. Food and Drug Administration. Fast Track Designation Requests.
U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.

CONTACT:H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark
+45 3630 1311
[email protected]

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