Posted by Michael Wonder on 27 Nov 2023
Krystal Biotech announces EMA validation of marketing authorisation application for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA.
Krystal Biotech today announced that the Company’s marketing authorisation application to the EMA's CHMP for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa has been validated and is now under CHMP review.
