Pharma Focus America

Mesoblast to Submit Biologics License Application for FDA Approval of Ryoncil® Next Week

Monday, July 01, 2024

Mesoblast Limited (Nasdaq: MESO; ASX: MSB), a leader in developing allogeneic cellular medicines for severe inflammatory diseases, announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) next week for Ryoncil® (remestemcel-L). This application aims to gain FDA approval for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast utilizes proprietary mesenchymal lineage cell therapy technology to develop a portfolio of late-stage product candidates. These therapies release anti-inflammatory factors that modulate the immune system, reducing harmful inflammation. With extensive global intellectual property protection until at least 2041, Mesoblast's manufacturing processes produce scalable, cryopreserved, off-the-shelf cellular medicines. These are designed to meet pharmaceutical criteria and ensure broad accessibility worldwide.

The company's pipeline includes remestemcel-L for inflammatory conditions in children and adults, including steroid-refractory acute graft versus host disease and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is also being developed for chronic heart failure and chronic low back pain. Mesoblast has commercialized products in Japan and Europe through licensees and established commercial partnerships in Europe and China for selected Phase 3 assets.

Headquartered in Australia with operations in the United States and Singapore, Mesoblast is listed on the Australian Securities Exchange (MSB) and Nasdaq (MESO).

 

Source: globenewswire.com

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