Idebenone PDUFA Date (Chiesi Global Rare Diseases)
FDA PDUFA decision date for Idebenone is February 28, 2026. Developed by Chiesi Global Rare Diseases. Indication: Leber hereditary optic neuropathy (LHON). Current status: Verifying.
Indication
Leber hereditary optic neuropathy (LHON)
Notes
PDUFA date passed. Awaiting public FDA decision. Already approved as Raxone in EU.
Regulatory details
- Company: Chiesi Global Rare Diseases
- Therapeutic area: Rare Disease / Ophthalmology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-02-28
- Outcome: Pending