- Mesoblast (MSB) provides update on remestemcel-L after meeting with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT)
- The meeting was held to address issues identified in the the company’s complete response letter to the FDA Office
- The Office reportedly indicated Mesoblast’s approach to address items raised in the letter was reasonable
- Mesoblast has generated new substantial data and will resubmit for the Biologics Licence Application
- Shares are trading 2.57 per cent higher at $1.40 each
Mesoblast (MSB) has provided an update on its remestemcel-L product after meeting with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT).
Remestemcel-L has been designed for the treatment of steroid refractory acute graft versus host disease (SR-aGVHD) in children. SR-aGVHD is severe inflammation in the bloodstream caused by complications in bone marrow transplants.
The meeting was held to address potency assay and chemistry, manufacturing, and controls identified in the company’s complete response letter for the product.
The company says OTAT indicated the company’s approach to address the items in the complete response letter is reasonable. OTAT reportedly specified the in-vitro immunomodulatory intended to measure for potency is a critical quality attribute for the product.
Mesoblast said it has generated substantial new data that it believes establishes relevance of the in-vitro immunomodulatory activity of remestemcel-L in the in-vivo clinical effect of the product in the phase three trial of children with SR-aGVHD.
MSB advises it will submit the new data and address other issues identified in the complete response letter as required for the Biologics Licence Application resubmission.
Shares were trading 2.57 per cent higher today at $1.40 each at 12:00 pm AEDT.