Posted by Michael Wonder on 09 Jan 2023
Krystal Biotech announces FDA’s 3 month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa
9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that based on manufacturing information submitted to the Agency on 20 December 2022, in response to an information request, the PDUFA date has been revised to 19 May 2023, and proposed labelling discussions to no later than 20 April 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.
