Oral narcolepsy treatment put on FDA fast track for review

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Lu AH69593, an experimental oral therapy Lundbeck is developing to treat narcolepsy.

The FDA awards this designation to help speed the development of medicines designed to treat serious disorders and fill unmet medical needs. With this designation in hand, Lundbeck will get access to perks such as more frequent feedback from the FDA during the drug-development process.

“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,” Johan Luthman, PhD, executive vice president for research and development at Lundbeck, said in a company press release.

Narcolepsy is a rare disorder defined by the uncontrolled urge to sleep during the day. In type 1 narcolepsy, which is generally more severe, the disease is characterized by low levels of orexin (also known as hypocretin), a signaling molecule that helps regulate sleepiness.

Orexin normally acts by binding to one of two molecular receptors, orexin receptor 1 and orexin receptor 2. Orexin signaling through the second receptor is thought to be especially important for regulating sleep and wakefulness.

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Lu AH69593 is an agonist of orexin receptor 2, meaning the treatment is designed to bind to this receptor and activate it, in much the same way that naturally occurring orexin does. The drug aims to normalize orexin signaling in the brain, restoring a normal balance of sleepiness and wakefulness.

Luthman said the FDA 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 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,” Luthman said. “We are encouraged by the opportunity to work closely with the FDA as we advance Lu AH69593.”

Lundbeck is running a Phase 1 clinical trial (NCT07613710) with the main aim of testing the safety and pharmacological properties of Lu AH69593 in healthy volunteers. The study will also test Lu AH69593 in a small number of narcolepsy patients. The Phase 1 trial is recruiting participants at a site in Helsinki.