Aug 04, 2023 / 12:00AM GMT
Silviu Itescu - Mesoblast Limited - Founder, CEO, MD, Chairman of Scientific Advisory Board & Executive Director
Thank you, everybody. Joining me today is Dr. Eric Rose, Chief Medical Officer; and Geraldine Storton, our Head of Quality and Regulatory Affairs.
Today, we received a complete response from the U.S. FDA for BLA steroid-refractory acute graft versus host disease in children. The FDA has informed us that they require more data to support marketing approval. To obtain the data that is required, Mesoblast will conduct a targeted -- a very targeted controlled study in the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial strategy, which has envisioned a sequenced progression from pediatric to the adult steroid-refractory GVHD indication. It is important to note that adults comprise the vast majority of patients with this devastating disease, 80% of the GVHD market.
Importantly, FDA's inspection of our manufacturing process resulted in no observed concerns. The agency raised no safety issues across more than 1,300 patients
Mesoblast Ltd bLA for Graft Versus Host Disease Call Transcript
Aug 04, 2023
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