COPENHAGEN
Lundbeck's Lu AH69593 wins Fast Track designation for narcolepsy
- Sponsor
- H. Lundbeck A/S $HLUKY
- Drug
- Lu AH69593
- Indication
- narcolepsy
FDA granted Fast Track designation to Lundbeck's Lu AH69593, an investigational oral orexin 2 receptor agonist, for the treatment of narcolepsy. Orexin 2 signalling drives wakefulness; Lundbeck is one of several sponsors (Takeda, Centessa, Alkermes) pursuing OX2R agonism as a mechanism-targeted approach to narcolepsy type 1 (orexin-deficient) and adjacent hypersomnias.
What this means
Lu AH69593 is an experimental medicine for narcolepsy, a condition of excessive daytime sleepiness. Today the FDA granted it Fast Track status, which aims to speed up its review and potential approval. This could mean patients get access to a new treatment sooner if the drug proves safe and effective in ongoing trials.