The Mesoblast Limited (ASX: MSB) share price is trading lower on Monday.
The shares of the global leader in cellular medicines for inflammatory diseases have been dragged lower by a broad market sell off which has offset a positive announcement.
At the time of writing the Mesoblast share price is down 2.5% to $2.93.
What did Mesoblast announce?
This morning Mesoblast announced that it has submitted its completed Biologics License Application (BLA) to the United States Food and Drug Administration (US FDA) for Ryoncil (remestemcel-L).
Ryoncil is its lead allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SRaGVHD).
What is acute GVHD?
Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT).
There are over 30,000 patients worldwide undergoing an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.
In patients with the most severe form of acute GVHD, mortality is as high as 90% despite optimal institutional standard of care. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.
What now?
According to the release, the company filed the final module of the rolling BLA submission, covering quality control and manufacturing, with the FDA on January 31.
Mesoblast has requested a priority review of the BLA by the FDA under the product candidate's existing Fast Track designation for SR-aGVHD.
This means that if it is approved, RYONCIL is expected to be launched in the US later this year.
The company's chief executive, Dr Silviu Itescu, said: "This is a major corporate milestone for Mesoblast. We look forward to working closely with the FDA to potentially bring RYONCIL to market and providing our innovative biologic therapy to the many children with this life-threatening condition."
