Mesoblast (MESO,MSB.AX) announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration for Ryoncil (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
The company said the period of statutory exclusivity means that the FDA will not approve another mesenchymal stromal or stem cell (MSC) products for this indication during the 7-year period from the approval of Ryoncil.
Separately, Mesoblast has biologic exclusivity preventing another sponsor from referencing the Ryoncil biologic license application (BLA) until December 2036, twelve years from its first approval which would prevent market entry by a biosimilar.
The statutory exclusivities are in addition to Mesoblasts strong U.S. intellectual property position on MSC composition of matter, manufacturing and indications, including SR-aGvHD, that provide a commercial barrier to entry against competitors through 2044.
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