Krystal Clears Path To Market For Topical Gene Therapy Vyjuvek

 
• By Alaric DeArment
  
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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...

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