FDA Grants Seven-Year Orphan-Drug Exclusivity for Ryoncil®
Thursday, May 15, 2025
Mesoblast, a global company specialising in allogeneic cellular medicines for inflammatory diseases, has received seven years of orphan-drug exclusivity from the U.S. Food and Drug Administration (FDA) for its product Ryoncil® (remestemcel-L). This approval covers the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older.
The orphan-drug designation means that no other mesenchymal stromal or stem cell (MSC) therapy for this specific use will be approved by the FDA during this exclusivity period, which began with Ryoncil®’s approval.
In addition to this, Mesoblast holds biologic exclusivity, which blocks other companies from referencing Ryoncil®’s biologic licence application (BLA) until December 2036. This protection, lasting 12 years from the product’s first approval, delays potential market competition from biosimilars.
These protections are further supported by Mesoblast’s intellectual property rights in the U.S., covering the MSC composition, manufacturing processes, and treatment uses including SR-aGvHD. These patents are expected to provide additional commercial protection until 2044.
Source: globenewswire.com
