Krystal Biotech's VYJUVEK Secures Marketing Authorization From Japan's MHLW

(RTTNews) - Krystal Biotech, Inc. (KRYS), Friday announced that the company's VYJUVEK has secured marketing authorization from Japan's Ministry of Health, Labour and Welfare for the treatment of wounds in patients with dystrophic epidermolysis bullosa.

The approval was based on a comprehensive clinical dataset, including results from an open label extension study, which showed that VYJUVEK was well tolerated and exhibited a safety profile in Japanese patients.

As per the approval, VYJUVEK is intended for use only in patients with a definite diagnosis of dystrophic epidermolysis bullosa, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their family members.

Notably, the timing for availability of VYJUVEK in Japan will depend on completion of reimbursement procedures. However, the company expects to launch in Japan by the 2025 end.

Currently, KRYS is trading at $150.52, up 0.35 percent on the Nasdaq.