The FDA has granted Mesoblast’s stem cell therapy, Ryoncil (remestemcel-L), seven years of orphan drug exclusivity for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children ages 2 months and older, the company announced May 14. The exclusivity designation means the FDA will not approve another mesenchymal stromal or stem cell product for the same condition until 2032.

SR-aGvHD is a serious and potentially fatal complication of allogeneic stem cell transplants, which are often used to treat blood cancers, inherited blood disorders and immune system diseases. In this condition, donor immune cells attack the recipient’s body. When patients do not respond to steroids, the standard first-line treatment, options are limited.

It is made from bone marrow-de

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