regulatory
confidence high
sentiment positive
materiality 0.60
Alkermes announces orphan drug designations for alixorexton in US for IH and EU for narcolepsy
Alkermes plc.
- FDA grants orphan drug designation to alixorexton for idiopathic hypersomnia.
- European Commission grants orphan drug designation to alixorexton for narcolepsy.
- Alixorexton is an oral OX2R agonist in phase 3 for narcolepsy and phase 2 for IH.
- ODD provides market exclusivity (7 yrs US, 10 yrs EU) if approved.
- Alixorexton previously received FDA Breakthrough Therapy for NT1.