FDA notifies 3-month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa- Krystal Biotech, Inc.
Krystal Biotech, Inc. announced that FDA notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.
The manufacturing information submitted by the Company included additional information about a replaced hardware unit in the concentration step of the manufacturing process and comparability data supporting the use of the unit. The unit did not affect processing parameters or product contact materials. The FDA considered this new information as a major amendment to the application that will require additional time for review.
The BLA late-cycle review meeting was completed on December 15, 2022. During this meeting, the FDA indicated that there will be no Advisory Committee meeting for B-VEC and a Risk Evaluation and Mitigation Strategies (REMS) program is not needed for the B-VEC application. All pre-approval inspections of clinical sites and internal manufacturing and testing facilities have been successfully completed.
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