Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs

Mesoblast Limited announced it received a Biologics License Application (BLA) filing number from the FDA and requested modular review for rexlemestrocel-L, a cellular therapy for preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients with left ventricular assist devices. The therapy has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, enabling rolling and priority reviews. The announcement comes as the FDA released new guidance supporting regulatory flexibility for orphan rare diseases with high mortality.