Mesoblast gets FDA BLA filing number for rexlemestrocel-L to treat end-stage heart failure with LVADs

Mesoblast has received a Biologics License Application (BLA) filing number from the FDA for rexlemestrocel-L, a cell therapy aimed at preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients with left ventricular assist devices (LVADs). The therapy has Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations, enabling priority and rolling reviews. This marks a significant step toward regulatory approval, potentially offering a new treatment for high-risk heart failure patients. Mesoblast plans to work closely with the FDA to advance this therapy's availability.