FDA Accepts Krystal Biotech's Filing For Genetic Skin Disorder Candidate Under Priority Review

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s KRYS Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB).

The regulatory agency has granted Priority Review designation and assigned a target actin date of February 17, 2023.

The Biologics License Application (BLA) submission for B-VEC is supported by the clinical data readouts from the GEM-3 and GEM-1/2 trials.

The agency has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

Suma Krishnan, Co-Founder and President, Research & Development, commented: ”We are delighted to receive the FDA's acceptance of our BLA submission and move one step closer to potentially bringing a medicine to fundamentally treat DEB patients. We are committed to working closely with the FDA to bring this potential, first-ever treatment to patients living with DEB as quickly as possible.”

B-VEC was granted Fast Track designation and Regenerative Medicine Advanced Therapy (RMAT) by the regulatory agency for the treatment of dystrophic epidermolysis bullosa (DEB).

Krystal plans to seek marketing authorization from the European Medicines Agency (EMA) in the second half of 2022.

The FDA grants Priority Review that shortens review period of BLA, applicable for medicines which may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.

Price Action : Krystal shares closed Thursday’s trading at $74.41