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)
Copyright (c) 2025 Dow Jones & Company, Inc.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.