FDA accepts NDA for Zimura in geographic atrophy and sets PDUFA date.- IVERIC bio
IVERIC bio announced that the FDA has completed its filing review and accepted the company’s New Drug Application (NDA) for Zimura (avacincaptad pegol or ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
The NDA has been granted Priority Review with a Prescription Drug User Fee Act goal date of August 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.
The NDA submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials. ACP is the only investigational product for the treatment of GA to achieve the pre-specified 12-month primary endpoint in two phase III pivotal trials with observed efficacy rates of up to 35%. In addition, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation for GA secondary to AMD.
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