Krystal Biotech announces EMA validation of MAA for VYJUVEK

Krystal Biotech announced that the Company’s Marketing Authorization Application, MAA, to the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, for VYJUVEK for the treatment of dystrophic epidermolysis bullosa, DEB, has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024. “The validation of our MAA for review by CHMP is an important step toward our goal to bring VYJUVEK to patients in the EU who are living with DEB,” said Suma Krishnan, President, Research & Development, Krystal Biotech, Inc. “We look forward to working closely with EMA through the MAA review process, as VYJUVEK has the potential to fulfil an unmet medical need for DEB patients and their families.” In September 2023, Krystal Biotech received a positive opinion from the EMA Pediatric Committee on the Pediatric Investigation Plan for VYJUVEK for the treatment of DEB. Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU. Previously, VYJUVEK received Orphan Drug Designation and PRIority Medicines eligibility from the EMA.