Mesoblast Limited (ASX:MSB) Achieves FDA Approval for RYONCIL
Regulatory Milestone
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) announced that RYONCIL (remestemcel-L) has received approval from the Food and Drug Administration (FDA). This makes RYONCIL the first mesenchymal stromal cell (MSC) therapy approved in the United States for any indication, specifically for steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older.
Clinical Efficacy
The FDA approval is based on a Phase 3 trial where 70% of children with SR-aGvHD achieved an overall response by Day 28 of treatment with RYONCIL, significantly improving their prognosis. The clinical study included patients with high-severity disease, with 89% exhibiting Grade C or D conditions. RYONCIL was well tolerated, with over 85% of participants completing the treatment without any interruptions.
Executive Comments
Dr. Silviu Itescu, Chief Executive of Mesoblast, expressed pride in the company’s commitment to the GVHD community, stating, “We are very pleased that the FDA has granted approval of RYONCIL® and are proud of the company’s commitment to the GVHD community in bringing this important new treatment to children and families with no other acceptable options.” He also highlighted plans to pursue further approvals for their late-stage products.
Availability and Future Plans
RYONCIL will be distributed at transplant centres and hospitals throughout the United States. The company aims to expand its indications for RYONCIL and advance other products in its development pipeline, including therapies for cardiovascular diseases and inflammatory pain conditions.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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