Mesoblast Limited resubmitted its Biologics License Application to the US FDA

Mesoblast Limited (ASX: MSB) announced that it had resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration for clearance of remestemcel-L in the treatment of kids with steroid-refractory acute graft versus host disease (SR-aGVHD). The company reacted to the CRL and the additional FDA advice by generating and submitting new data and analysis in the resubmission that demonstrate considerable evidence of remestemcel-efficacy L's in paediatric SR-aGVHD. The following are included in the resubmission:

• New long-term survival data of children registered in the Phase 3 trial displaying durability of treatment effect via at least 4 years.
• As per the new data, the approved potency test has reduced variability and can sufficiently demonstrate production uniformity and reproducibility.

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