Krystal Biotech Announces FDA's 3-Month Extension Of BLA PDUFA Date And Regulatory Update For B-VEC

(RTTNews) - Krystal Biotech, Inc. (KRYS) Monday announced the U.S. Food and Drug Administration's 3-month extension of BLA PDUFA Date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa.

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 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.

"While we are disappointed that this change was viewed as a major amendment, we are committed to working with the FDA as it completes its review of the B-VEC application," said Krish S. Krishnan, Chairman & CEO at Krystal Biotech. "We will continue our commercial readiness efforts and upon approval bring this important treatment to DEB patients as soon as possible."