Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the US FDA’s Approval for Dystrophic Epidermolysis Bullosa in Patients Aged ≥6 Months
Shots:
- The approval was based on the 2 studies (GEM-1/2) & (GEM-3) trials evaluating Vyjuvek, the first-ever redosable gene therapy. The product is expected to be available in the US in Q3’23
- The P-III trial (GEM-3) results published in the NEJM demonstrated that the trial met its 1EPs of complete wound healing @6mos. and its 2EPs of complete wound healing @3mos. The therapy was well tolerated with no drug-related SAEs or discontinuations due to treatment-related events
- In the (GEM-1/2) trial, the results showed durable wound closure, expression of full-length COL7 in the skin, and anchoring fibril assembly with minimal reported AEs. The results were published in Nature Medicine
Ref: Globenewswire | Image: Krystal Biotech
Related News:- Krystal Biotech Reports P-III Trial (GEM-3) Results of Beremagene Geperpavec for the Treatment of Dystrophic Epidermolysis Bullosa
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
