FDA issues a complete response letter regarding the NDA for idebenone for Leber hereditary optic neuropathy in the United States

Chiesi

5 March 2026 - Idebenone remains marketed in multiple countries outside the US as a treatment for Leber hereditary optic neuropathy.

Chiesi Global Rare Diseases today announced that the US FDA issued a complete response letter for idebenone for the treatment of adolescents and adults with Leber hereditary optic neuropathy.

Read Chiesi press release 

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier , Registration