Krystal Biotech Says EMA Validated MAA For VYJUVEK For Dystrophic Epidermolysis Bullosa

RTTNews | Pred 563 dňami
Stocktwits
Krystal Biotech Says EMA Validated MAA For VYJUVEK For Dystrophic Epidermolysis Bullosa

(RTTNews) - Biotechnology company Krystal Biotech, Inc. (KRYS) announced Monday 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 (beremagene geperpavec-svdt or B-VEC) 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.

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 (PRIME) eligibility from the EMA.

Značky: KRYS
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