Zevra Therapeutics Announces Resubmission Of Arimoclomol New Drug Application To The U.S. Food And Drug Administration
Read the full statement from Zevra Therapeutics here:
Here is a summary of the article:
Zevra Therapeutics Resubmits NDA for Arimoclomol: Zevra is a rare disease therapeutics company that has developed arimoclomol, an investigational drug for the treatment of Niemann-Pick disease type C (NPC), a genetic and fatal neurological disorder.
Arimoclomol Addresses Lysosomal Dysfunction in NPC: Arimoclomol is designed to improve the function of lysosomes, which are cellular compartments that transport and metabolize lipids.
Zevra Expects FDA Review within Six Months: Zevra resubmitted its NDA for arimoclomol on December 22, 2023 , after receiving a complete response letter from the FDA in June 2023.
Zevra Prepares for Commercial Launch of Arimoclomol: Zevra is accelerating its launch preparations in anticipation of FDA approval and aims to bring arimoclomol to the NPC community as soon as possible.
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