Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C

RTTNews | Pred 575 dňami
Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C

(RTTNews) - Rare disease therapeutics company Zevra Therapeutics, Inc. (ZVRA) announced Monday that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has deemed the arimoclomol NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission.

As a result, the FDA has assigned a PDUFA action date of June 21, 2024, and currently intends to present the resubmission for discussion in an advisory committee.

Zevra believes that its resubmission of the arimoclomol NDA addresses the concerns previously raised in the June 2021 complete response letter (CRL) issued by the FDA in response to the prior arimoclomol NDA filing.

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Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

Zevra Therapeutics, Inc. (ZVRA) announced Monday the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC).
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Zevra Therapeutics Resubmits Arimoclomol NDA To FDA

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Zevra Therapeutics, Inc. (ZVRA) announced Wednesday it resubmitted its New Drug Application (NDA) for arimoclomol to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Arimoclomol is an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC).
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