FDA rejects Mesoblast's cell therapy for bone marrow transplant complications

Mesoblast

04/08/2023 02:57

Aug 3 (Reuters) - The U.S. Food and Drug Administration
had rejected Mesoblast's  MSB.AX   MESO.O  cell therapy for
children under 12 years of age for treating a type of
complication that occurs after a stem cell or bone marrow
transplant, the company said on Thursday.
    The health regulator required more data to support marketing
approval for the company's lead product remestemcel-L, Mesoblast
said in a statement.
    The rejection deals a blow to Mesoblast's hopes for a
potential launch of the therapy, especially after its
fundraising efforts over the last two years.
    The drug developer was seeking the FDA's approval for a cell
therapy to treat children with a type of graft versus host
disease (GvHD), whose symptoms did not respond to standard
steroid therapy or developed recurrence while continuing
treatment.
    There are no approved therapies in children for the
condition in which the donor bone marrow or stem cells attack
the recipient.
        

 (Reporting by Pratik Jain, Sriparna Roy and Shivani Tanna in
Bengaluru; Editing by Krishna Chandra Eluri and Sherry
Jacob-Phillips)
 ((Pratik.Jain@thomsonreuters.com;))