Lundbeck Secures FDA Fast Track for Narcolepsy Drug

FDA grants fast track designation for Lundbeck’s Lu AH69593

Lundbeck has secured fast track designation from the US FDA for its investigational treatment, Lu AH69593, to treat narcolepsy.The post FDA grants fast track designation for Lundbeck’s Lu AH69593 appeared first on Hospital Management.

FDA Grants Fast Track Designation to Investigational Narcolepsy Treatment

The oral orexin 2 receptor agonist currently in phase 1b development for patients with narcolepsy. Key takeaways: The FDA granted Fast Track designation to Lu AH69593 to expedite its development and review. The investigational compound is a small-molecule orexin 2 receptor agonist designed to enhance wake-promoting signaling. Lundbeck is currently evaluating the drug’s safety, tolerability, and pharmacokinetic profile in an ongoing phase 1b cli…

Lundbeck secures FDA Fast Track for narcolepsy drug

Designation supports development of novel orexin therapy