FDA Grants Approval to Vyjuvek, the First Ever Redosable Gene Therapy

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Krystal Biotech treatment to support patients with dystrophic epidermolysis bullosa.

Krystal Biotech, an organization focused on developing and commercializing genetic medicines for patients with rare diseases, is officially receiving FDA approval for Vyjuvek, a treatment geared towards patients aged six months or older with dystrophic epidermolysis bullosa (DEB). According to the company, Vyjuvek is the first-ever redosable gene therapy and the first and only medicine approved by the FDA for the treatment of DEB that can be administered by a healthcare professional in either a healthcare professional setting or in the home. As a part of the approval, AmerisourceBergen will support product commercialization.1

“Cell and gene therapy products can transform how certain diseases are treated, offering significant promise for patients around the world. Our goal is to provide developers with access to services across the product lifecycle to simplify the commercialization process and help them achieve the outcomes they desire,” said Lung-I Cheng, Vice President of Cell & Gene Therapy at AmerisourceBergen. “We are thrilled to support Krystal Biotech and look forward to providing the services needed to help them drive commercial success and ensure patients have timely and reliable access to the treatment.”2

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References:

1. Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa. GlobeNewswire. May 19, 2023. Accessed May 24, 2023. https://www.globenewswire.com/news-release/2023/05/19/2672756/0/en/Krystal-Biotech-Receives-FDA-Approval-for-the-First-Ever-Redosable-Gene-Therapy-VYJUVEK-beremagene-geperpavec-svdt-for-the-Treatment-of-Dystrophic-Epidermolysis-Bullosa.html

2. AmerisourceBergen to Support Commercialization of Krystal Biotech’s Gene Therapy. AmerisourceBergen. May 19, 2023. Accessed May 24, 2023. https://www.amerisourcebergen.com/newsroom/media-statements/amerisourcebergen-to-support-commercialization-of-krystal-biotech-gene-therapy