ASX Health Stocks: Mesoblast responds to questions arising from US FDA meeting
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is trading lower by 0.26% at the time of writing, compared to the broader index which is down by 0.30%.
Cellular medicines specialist Mesoblast (ASX:MSB) has provided an update of its meeting with the US FDA Office of Tissues and Advanced Therapies (OTAT).
Mesoblast had requested the meeting to address the appropriateness of a potency assay related to manufacturing and controls (CMC) for remestemcel-L, its lead drug used to treat acute graft versus host disease (SR-aGVHD) in children.
The OTAT has responded with positive news, indicating that Mesoblast’s approach to address the outstanding CMC items is reasonable.
However, OTAT says the relevance of this activity to clinical outcomes should still be established.
Mesoblast has responded by generating substantial new data that it believes establish the relevance of the proposed in vitro immuno-modulatory activity of remestemcel-L.
It will now provide these new data to OTAT and address their concerns as required.
GVHD is a severe inflammation in the bloodstream caused by complications of bone marrow transplants.
The disease occurs in up to 50% of the 30,000 patients who receive an allogeneic bone marrow transplant each year, primarily during treatment for blood cancers.
In patients with the most severe form of GVHD, mortality can be as high as 90%. There are currently no therapies approved for treating SR-aGVHD in children under the age of 12.
Mesoblast meanwhile has a strong and extensive global intellectual property portfolio with patent protection extending through to at least 2041 in major markets.
In other healthcare news today, Trajan Group (ASX:TRJ) has has completed the US$7.7 million takeover of US-based LEAP PAL Parts and Consumables.
LEAP operates in the specialised parts of medical instruments business, which supports customers that operate automated laboratory workflows.