US FDA approves Mesoblast's cell therapy for graft-versus-host disease (updated)

Mesoblast

18/12/2024 22:40

(Adds details on therapy in paragraphs 2, details on disease in
paragraphs 4 and 5)
       Dec 18 (Reuters) - The U.S. Food and Drug Administration
on Wednesday approved Mesoblast's  MSB.AX  cell therapy for
treating a type of complication that occurs after a stem cell or
bone marrow transplant called graft-versus-host disease (GVHD).
    The therapy, branded as Ryoncil, is the first mesenchymal
stromal cell therapy approved to treat pediatric patients aged
two months and older whose GVHD symptoms have not responded to
standard steroid therapy.
    The company did not immediately respond to Reuters request
for comment on pricing and availability.
    GVHD is a complication that might occur after a cell
transplant, where the donated stem cells attack the recipient’s
cells, viewing them as an unfamiliar threat.
    Mesenchymal stromal cells are spindle-shaped cells that can
have various roles in the body and can differentiate into
multiple other types of cells. The cells are isolated from the
bone marrow of healthy adult human donors.
    The FDA advises the treating physician should monitor the
Ryoncil infusion, and discontinue it if there is any evidence of
a reaction such as shortness of breath, low blood pressure,
fever, or rapid breathing, among others.
    Last year, the U.S. health regulator declined to approve the
therapy as it required more data to support marketing approval.

 (Reporting by Sriparna Roy in Bengaluru; Editing by Vijay
Kishore)
 ((Sriparna.Roy@thomsonreuters.com;))