Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa - Seite 3

VYJUVEK is expected to be available in the United States in the third quarter of 2023, and the Company will begin the promotion of VYJUVEK immediately. To meet the needs of patients, caregivers, and families as they start and continue their VYJUVEK treatment journey, the Company has developed Krystal Connect, a personalized support program. The program includes resources that can answer questions about VYJUVEK, verify health benefits, support treatment planning and administration and provide information about financial assistance for eligible patients. For more information, patients, caregivers and healthcare professionals can call Krystal Connect at 1-844-5-KRYSTAL.

With this approval, the FDA issued the Company a Rare Pediatric Disease Priority Review Voucher (PRV), which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. The PRV program is designed to encourage the development of new drugs for the prevention or treatment of rare diseases.

“With the FDA approval of VYJUVEK, the DEB population has reached a monumental milestone in the treatment of this horrible disorder. Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Brett Kopelan, Executive Director of debra of America, the national organization dedicated to improving the lives of all people living with EB in the US. Mr. Kopelan added, “we thank Krystal for their dedication and commitment to bringing VYJUVEK to fruition. People living with DEB will now have a significant chance of having an improved quality of life and debra will continue to work closely with Krystal to assure patients have ready access to VYJUVEK.”

Outside of the US, the European Medicines Agency has granted VYJUVEK orphan drug designation and PRIME (PRIority MEdicines) eligibility for the treatment of DEB. The Company anticipates starting the official Marketing Authorization Application procedure in the second half of 2023 with a potential approval in 2024. The Company is also working with the Pharmaceuticals and Medical Devices Agency in Japan to study VYJUVEK and seek approval for potential launch in 2025.

Visit VYJUVEK.com for more information, including full Prescribing Information.

Investor Conference Call and Webcast

The Company will host an investor conference call and webcast to discuss the FDA’s approval of VYJUVEK on Friday, May 19, 2023, at 6 pm ET.