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FDA approves groundbreaking rub-on gene therapy for rare skin disorder.

1 min read
Source: Reuters
FDA approves groundbreaking rub-on gene therapy for rare skin disorder.
Photo: Reuters
TL;DR

The US FDA has approved Krystal Biotech's Vyjuvek, a topical gene therapy for patients with dystrophic epidermolysis bullosa, a rare genetic skin disorder. The therapy is expected to be available in the US in Q3 2023 and is Krystal's first to be approved in the country. The FDA approval is supported by data from early-to-mid-stage and late-stage studies, which showed Vyjuvek completely healed wounds in about 65% of the participants.

Topics:businesshealthcare#dystrophic-epidermolysis-bullosa#fda#gene-therapy#healthcare#krystal-biotech#vyjuvek
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  1. U.S. FDA approves Krystal Biotech's skin-disorder gene therapy  Reuters
  2. The FDA just approved rub-on gene therapy that helps “butterfly” children  MIT Technology Review
  3. Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease  FiercePharma
  4. FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy  STAT
  5. Rare Skin Blistering Condition Gets First Drug Approved  Medpage Today

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