Business
FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) 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. This period of statutory exclusivity means that the FDA will not
About this update from Mesoblast Limited
[{"type":"image","alt":"Mesoblast Limited","displaySize":"","headline":null,"caption":"Mesoblast Limited","className":"","disableSlideshowImg":false,"size":{"original":{"width":289,"height":38,"url":"https://media.zenfs.com/en/globenewswire.com/3a26a2f63129fae6650ef7618b48c2df"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/qVvwFFYM1KHQf5WBcCEDQw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTU1O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/3a26a2f63129fae6650ef7618b48c2df","width":289,"height":38}},"lazy":false},{"type":"text","content":"NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) 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.","length":435,"tagName":"p"},{"type":"text","content":"This 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.","length":451,"tagName":"p"},{"type":"text","content":"These statutory exclusivities are in addition to Mesoblast’s 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.","length":261,"tagName":"p"},{"type":"text","content":"About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.","length":504,"tagName":"p"...