Pharma News

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

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.

“Today’s landmark approval of Vyjuvek as the first redosable gene therapy ushers in a whole new paradigm to treat genetic diseases and is an important milestone for patients affected by DEB as well as their families and caregivers,” said Krish S. Krishnan, chairman and CEO of Krystal Biotech, Inc. “We offer our sincere gratitude to DEB patients, caregivers, investigators, US regulators, and our employees who made this approval possible.”

Reference: Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEKâ„¢ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa. May 19, 2023/ Globe Newswire

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