FDA rejects Chiesi Group's NDA for LHON oral drug (Eyes On Eyecare) - Mar 17, 2026 - "The FDA has issued a complete response letter (CRL) to Chiesi Global Rare Diseases in regards to its new drug application (NDA) for oral idebenone to treat Leber hereditary optic neuropathy (LHON)...The news was announced earlier this month after the previous Prescription Drug User Fee Act (PDUFA) target date passed on Feb. 28...The agency requested additional clinical data from adequate and well-controlled studies to further demonstrate the safety and effectiveness of idebenone in LHON..."
CRL • Leber Hereditary Optic Neuropathy
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