USA FDA – Vyjuvek: BLA approval ( Catapult’s regulatory round-up May)
The FDA has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above.
Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing.
It is the first re-dosable gene therapy as well as the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues.
Published on the 2nd of June 2023. Read the entire regulatory round-up for the month of May published and curated by Catapult here.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 février 2024). USA FDA – Vyjuvek: BLA approval ( Catapult’s regulatory round-up May). ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/vvd4
