FDA Extends Review of Zevra's Arimoclomol by Three Months

By Colin Kellaher

The U.S. Food and Drug Administration has extended by three months its review of an application from Zevra Therapeutics seeking approval of its lead product candidate arimoclomol for Niemann-Pick disease type C, a rare neurodegenerative disorder.

Zevra on Monday said the FDA needs more time to review additional analyses the Celebration, Fla., company provided in responses to recent information requests by the agency.

Zevra said the FDA set a new target action date of Sept. 21 for the application, adding that the agency confirmed that it plans to hold an advisory committee meeting that has yet to be scheduled.

Denmark's Orphazyme, which previously owned the arimoclomol program, initially filed for FDA approval of the drug in September 2020, but the agency rejected the application in June 2021.

Zevra, which acquired all of the assets and operations of Orphazyme related to arimoclomol in May 2022, resubmitted a new drug application for arimoclomol late last year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

03-04-24 0822ET