Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025.
Krystal Biotech today announced that the EMA’s CHMP cancelled the oral explanation regarding the Company’s marketing authorisation application for beremagene geperpavec-svdt for the treatment of dystrophic epidermolysis bullosa that was scheduled for 6 December 2024, and asked the Company to submit written responses to the remaining outstanding issues.
