Krystal Biotech Reports EMA’s Validation of Vyjuvek for MAA to Treat Dystrophic Epidermolysis Bullosa (DEB)
Shots:
- The EMA has validated the MAA of Vyjuvek for the treatment of DEB & is now under CHMP review. A CHMP opinion is anticipated in the H2’24
- In Sep 2023, the company also received a positive opinion from the EMA Pediatric Committee on the Pediatric Investigation Plan for Vyjuvek to treat DEB that will make the company eligible for up to an additional 2yrs. of marketing exclusivity in the EU, on top of the 10yrs.
- Previously, Vyjuvek received ODD & PRIME eligibility from the EMA
Ref: Krystal Biotech | Image: Krystal Biotech
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
