May 19 (Reuters) - The U.S. Food and Drug Administration on Friday approved Krystal Biotech Inc's (KRYS.O) first-of-its kind topical gene therapy for patients with a genetic skin disorder, sending its shares up 7% in afternoon trading.
Patients with the rare dystrophic epidermolysis bullosa disorder suffer from open wounds, causing skin infections and are at an increased risk of vision loss, scarring and skin cancer.
The therapy, Vyjuvek, is expected to be available in the United States in the third quarter of 2023, Krystal Biotech CEO Krish Krishnan told Reuters ahead of the FDA decision.
Our intent is to provide access to all the patients if possible in the United States," Krishnan said.
About 9,000 to 10,000 people suffer from dystrophic epidermolysis bullosa globally, including a U.S. population of about 3,000 patients, according to Krystal Biotech.