On Monday, Abeona Therapeutics Inc ABEO introduced a regulatory replace for prademagene zamikeracel (pz-cel).
The FDA has issued a Full Response Letter (CRL) in response to the corporate’s Biologics License Software (BLA) for pz-cel for the therapy of sufferers with recessive dystrophic epidermolysis bullosa (RDEB).
The CRL follows the completion of Abeona’s Late Cycle Overview Assembly with the FDA in March 2024.
On the Late Cycle Overview Assembly and in a subsequent info request, the FDA famous that sure extra info wanted to fulfill Chemistry Manufacturing and Controls (CMC) necessities.
In response, the corporate submitted plans to the FDA with the dedication to supply CMC knowledge previous to BLA approval and full validation studies after approval in mid-2024.
As well as, the corporate mentioned these plans with the FDA in a subsequent casual assembly.
Within the CRL, the FDA indicated that the proposed timing of the information submission by Abeona would require extra time for the FDA to finish its evaluation by the Could 25, 2024, PDUFA date.
The data wanted to fulfill the CMC requests within the CRL pertains to validation necessities for sure manufacturing and launch testing strategies, together with some captured within the observations in the course of the FDA’s pre-license inspection (PLI).
The CRL didn’t determine any deficiencies associated to the scientific efficacy or scientific security knowledge within the BLA, and the FDA didn’t request any new scientific trials or scientific knowledge to help the approval of pz-cel.
The BLA for pz-cel was accepted for submitting and granted precedence evaluation designation by the FDA in November 2023.
Value Motion: ABEO shares are down 45.10% at $4.04 on the final verify Tuesday.
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