{"id":963935,"date":"2026-05-18T08:05:01","date_gmt":"2026-05-18T12:05:01","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\/"},"modified":"2026-05-18T08:05:01","modified_gmt":"2026-05-18T12:05:01","slug":"krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\/","title":{"rendered":"Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>VYJUVEK approved for the treatment of DEB from birth with flexible administration options similar to those already granted in the United States, European Union, and Japan\u00a0<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB<\/em>\n      <\/p>\n<p>PITTSBURGH, May  18, 2026  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.krystalbio.com\/\" rel=\"nofollow\" target=\"_blank\"><u>Krystal Biotech, Inc.<\/u><\/a> (the \u201cCompany\u201d) (NASDAQ: KRYS) today announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK<sup>\u00ae<\/sup> (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (<em>COL7A1<\/em>) gene, from birth.<\/p>\n<p>VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human <em>COL7A1<\/em> gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers.<\/p>\n<p>\u201cThis latest approval brings VYJUVEK closer to patients in the United Kingdom and advances our vision of providing corrective therapy to as many DEB patients as possible,\u201d said Laurent Goux, Executive Vice President, Head of International at Krystal Biotech. \u201cWe are now focused on close collaboration with relevant authorities to support broad and rapid access across the United Kingdom.\u201d<\/p>\n<p>VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity.<\/p>\n<p>The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company\u2019s Phase 1\/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful\u00a0<em>COL7A1\u00a0<\/em>gene delivery and durable wound closure following topical administration, and was further supported by results from the Company\u2019s open label extension study and real-world experience with VYJUVEK.<\/p>\n<p>The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway.<\/p>\n<p>\u201cWe are delighted that VYJUVEK is now approved in the United Kingdom as the first and only corrective therapy for the treatment of DEB,\u201d said Suma Krishnan, President of Research and Development at Krystal Biotech. \u201cThis positive decision by the MHRA, our fourth approval following the United States, European Union, and Japan, reflects both the strength of our clinical dataset and our commitment to maximizing access to VYJUVEK worldwide.\u201d<\/p>\n<p>VYJUVEK was previously approved by the Food and Drug Administration in the United States in\u00a0May 2023, the European Commission in April 2025, and Japan\u2019s Ministry of Health, Labour and Welfare in July 2025.<\/p>\n<p>\n        <strong>UNITED KINGDOM INDICATION<\/strong><br \/>\n        <br \/>VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (<em>COL7A1<\/em>) gene, from birth.<\/p>\n<p>\n        <strong>About Krystal Biotech, Inc.<\/strong><br \/>\n        <br \/>Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK<sup>\u00ae<\/sup>, the Company\u2019s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit <a href=\"http:\/\/www.krystalbio.com\" rel=\"nofollow\" target=\"_blank\">www.krystalbio.com<\/a> to learn more or follow us on <a href=\"https:\/\/www.linkedin.com\/company\/krystal-biotech-inc\/\" rel=\"nofollow\" target=\"_blank\"><u>LinkedIn<\/u><\/a> and <a href=\"https:\/\/x.com\/KrystalBiotech\" rel=\"nofollow\" target=\"_blank\">X<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements regarding the timing of the launch of, and access to, VYJUVEK in the United Kingdom, and the completion of related reimbursement procedures; the potential duration of orphan market exclusivity in the United Kingdom; and the Company\u2019s commitment to maximizing access to VYJUVEK worldwide. Words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cwill,\u201d and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on the Company\u2019s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to reimbursement for VYJUVEK; uncertainties associated with the maintenance of orphan designation and exclusivity in the United Kingdom; commercial and competitive risks; and such other important factors as are set forth under the caption \u201cRisk Factors\u201d in the Company\u2019s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements except as required by law.<\/p>\n<p>\n        <strong>CONTACT<\/strong><br \/>\n        <br \/>\n        <strong>Investors and Media: <\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <br \/>St\u00e9phane Paquette, PhD<br \/>Krystal Biotech<br \/><a href=\"mailto:spaquette@krystalbio.com\" rel=\"nofollow\" target=\"_blank\">spaquette@krystalbio.com<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTkxMyM3NjA3OTcwIzIwOTE5Nzk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZjhkZGM2NzYtY2RlZi00NTA3LWE4ZmMtODhhY2ZmMjk1NTVlLTExMDM1NTAtMjAyNi0wNS0xOC1lbg==\/tiny\/Krystal-Biotech-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>VYJUVEK approved for the treatment of DEB from birth with flexible administration options similar to those already granted in the United States, European Union, and Japan\u00a0 VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB PITTSBURGH, May 18, 2026 (GLOBE NEWSWIRE) &#8212; Krystal Biotech, Inc. (the \u201cCompany\u201d) (NASDAQ: KRYS) today announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK\u00ae (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-963935","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"VYJUVEK approved for the treatment of DEB from birth with flexible administration options similar to those already granted in the United States, European Union, and Japan\u00a0 VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB PITTSBURGH, May 18, 2026 (GLOBE NEWSWIRE) &#8212; Krystal Biotech, Inc. (the \u201cCompany\u201d) (NASDAQ: KRYS) today announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK\u00ae (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment &hellip; Continue reading &quot;Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-18T12:05:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTkxMyM3NjA3OTcwIzIwOTE5Nzk=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa\",\"datePublished\":\"2026-05-18T12:05:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/\"},\"wordCount\":833,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTcyMTkxMyM3NjA3OTcwIzIwOTE5Nzk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/krystal-biotech-announces-united-kingdom-mhra-approval-of-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa\\\/\",\"name\":\"Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK\u00ae for the Treatment of Dystrophic Epidermolysis Bullosa - 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(the \u201cCompany\u201d) (NASDAQ: KRYS) today announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK\u00ae (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. 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