Krystal Clears Path To Market For Topical Gene Therapy Vyjuvek

The company estimates there are about 9,000 reimbursable patients with dystrophic epidermolysis bullosa worldwide and anticipates a third-quarter launch following FDA approval.

The FDA approved Krystal Biotech's Vyjuvek for DEB • Source: Shutterstock

Krystal Biotech, Inc. got a broad label for Vyjuvek (beremagene geperpavec-svdt) in dystrophic epidermolysis bullosa – covering both the recessive (RDEB) and dominant (DDEB) forms of the disease, and in patients aged 6 months and older – meaning it stands to have a strong commercial launch that could enable it to gradually expand the addressable patient population in the US and achieve sales approaching the $1bn mark.

Meanwhile, the company said pricing for the drug would vary considerably from one patient to the next due to differences in how much of the product patients would use depending on factors like disease severity and body surface area

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