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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. First: a refresh on Chiesi. As the business unit of the Italian Chiesi Group, Chiesi is a research-based international biopharmaceutical group with six research and development centers across the globe—including North Carolina in the United States. Its focus: Developing and marketing therapeutic solutions in respiratory health, rare diseases, and speciality care—see here for specifics on these areas (including ophthalmology). Next up: idebenone. Before we talk about this: Keep in mind that LHON is caused by mutations in mitochondrial DNA that impair Complex I of the electron transport chain (ETC), leading to acute central vision loss. Idebenone i23 hours ago • apk-inform.com
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