Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported that the United States Food and Drug Administration (US FDA) has agreed to the selection of Ryoncil™ as the commercial name for its lead allogeneic cell therapy remestemcel-L in the treatment of pediatric steroid-refractory acute graft versus host disease (aGVHD). Commercial plans for Ryoncil™ were presented at the 2020 Biotech Showcase being held this week in San Francisco, CA.
Mesoblast Chief Executive Dr. Silviu Itescu said: “We begin 2020 with great excitement as we prepare for potential FDA approval and US launch of our lead product candidate Ryoncil™ in pediatric aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant. The continued growth in revenues from royalties on sales in Japan of the related product TEMCELL®1 for aGVHD by our licensee provides important insight for our own US commercial plans. Together with our strategic partners, we are also looking forward to readouts of Phase 3 trials for our blockbuster product candidates in advanced chronic heart failure and chronic low back pain due to degenerative disc disease.”
The final module of the rolling Biologics License Application for Ryoncil™ will be filed with the FDA in January, following which the Company will request a priority FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, Ryoncil™ is planned to be launched in the US in 2020.
A webcast of the presentation is available via https://event.webcasts.com/starthere.jsp?ei=1278810&tp_key=f1494febd2 and as an archived webcast for 90 days on the Investors & Media section of the Company’s website at www.mesoblast.com.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.