Krystal Biotech Gets CHMP Backing for Vyjuvek Approval

Dow Jones

Feb 28, 2025

By Colin Kellaher

Krystal Biotech said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its Vyjuvek topical gene therapy for certain patients with the rare genetic skin disorder dystrophic epidermolysis bullosa, or DEB.

Krystal on Friday said the recommendation covers Vyjuvek for the treatment of wounds in people with DEB who have mutations in the collagen type VII alpha 1 chain gene, starting from birth.

The Pittsburgh biotechnology company said it expects a final decision from the European Commission, which generally follows the CHMP's advice, in the second quarter.

Krystal, which won U.S. Food and Drug Administration approval of Vyjuvek in 2023, recorded $290.5 million in net product revenue for the drug last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 28, 2025 07:58 ET (12:58 GMT)

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