Zevra Therapeutics Resubmits Arimoclomol’s NDA to the US FDA for Treating Niemann-Pick disease Type C (NPC)
Shots:
- Zevra Therapeutics has resubmitted the arimoclomol’s NDA on Dec 22, 2023 followed by the Complete Response Letter (CRL) in Jun’21 & anticipates the classification of resubmission as ‘Class 2’ with a 6mos. review period
- The updated data incorporates findings from various non-clinical studies, natural history comparisons, RWE data from ongoing EAPs in the US and the EU, and results from the 4yrs. extension of the P-II/III study that indicated that arimoclomol reduced the long-term progression of NPC
- Arimoclomol (oral) is the FIC, investigational product candidate which has been evaluated in 21 trials, incl. P-I, P-II and P-III studies enrolling 600 patients for NPC, other diseases and healthy subjects
Ref: Zevra Therapeutics | Image: Zevra Therapeutics
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
