USFDAJun 30, 2026, 08:39 PM
Mesoblast Receives FDA BLA Filing Number for Rexlemestrocel-L
AI Summary
Mesoblast Limited announced it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) for rexlemestrocel-L. The company has requested a modular review for the therapy, which is intended to prevent life-threatening gastrointestinal bleeding in end-stage heart failure patients with a left ventricular assist device (LVAD). Rexlemestrocel-L has both Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations, qualifying it for rolling and priority reviews. Mesoblast looks forward to collaborating with the FDA to make this treatment available.
Key Highlights
- Mesoblast received a Biologics License Application (BLA) filing number from the US FDA.
- Requested a modular review for rexlemestrocel-L for prevention of life-threatening gastrointestinal bleeding.
- Rexlemestrocel-L targets end-stage heart failure patients with a left ventricular assist device (LVAD).
- The therapy has Orphan Drug Designation for major mucosal bleeding events.
- Rexlemestrocel-L also holds Regenerative Medicine Advanced Therapy (RMAT) designation.
- FDA issued new guidance on regulatory flexibility for orphan rare diseases with high mortality.
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