Zevra Therapeutics Refiles Arimoclomol Application With FDA
27 Dezember 2023 - 2:24PM
Dow Jones News
By Colin Kellaher
Zevra Therapeutics has resubmitted a new drug application
seeking U.S. Food and Drug Administration approval of its lead
product candidate arimoclomol for Niemann-Pick disease type C, a
rare neurodegenerative disorder.
Zevra on Wednesday said it expects an acknowledgment letter from
the FDA that the resubmission is complete and setting a target
action date within 30 days.
The Celebration, Fla., company said it expects the FDA to
classify the resubmission as Class II, making it subject to a
review period by the agency within six months from the date of
submission.
Denmark's Orphazyme, which previously owned the arimoclomol
program, initially filed for FDA approval of the drug in September
2020.
However, the FDA in June 2021 issued a so-called complete
response letter, indicating that it wouldn't approve the
application in its current form and calling for additional
qualitative and quantitative evidence.
Zevra, which acquired all of the assets and operations of
Orphazyme related to arimoclomol in May 2022, said it believes it
has addressed the issues the FDA raised in the complete response
letter, and that it is accelerating launch preparations in
anticipation of an FDA approval.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 27, 2023 08:09 ET (13:09 GMT)
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