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Mesoblast announced that the FDA Oncology Advisory Committee (ODAC) voted 9:1 to support the efficacy of Ryoncil (remestemcel-L) in treating pediatric patients with steroid-refractic acute graft anti-host disease (SR-aGVHD).
company's press release that about 50 percent of patients receiving an allogeneic bone marrow transplant (BMT) develop acute GVHD.
more than 30,000 patients worldwide receive iso-BMT treatment each year, and the number is growing.
in the most severe acute GVHD patients, the mortality rate is as high as 90 per cent, despite optimal treatment.
, no FDA-approved treatment has been available for children under 12 years of age with SR-aGVHD.
Ryoncil is an interstumined stem cell that regulates T-cell-mediated inflammatory responses by inhibiting T-cell proliferation and reducing the production of inflammatory cytokines and interferons.
previously, its biopharmaceity application had been granted priority review by the FDA and was expected to receive a response from the FDA by September 30.
, Ryoncil is currently being developed for treatment of other rare diseases, and the company has initiated Phase 3 clinical trials to test its effectiveness in treating acute respiratory distress syndrome in patients with severe COVID-19.
phase 3 trial, which was previously publicly available on mesoblast's research and development pipeline (photo source: Mesoblast's official website), showed that the objective remission rate (ORR) on the 28th day after patients received Ryoncil treatment was 69%, a statistically significant increase from the 45% historical control rate.
patients who received at least one infusion treatment and followed up for 100 days had a mortality rate of 22%.
who received ineffective initial steroid treatment had a mortality rate of up to 70% on the 100th day. Dr Fred Grossman, chief medical officer at
Mesoblast, said: "Steroid incurable acute graft anti-host disease is an area in urgent need of innovative therapies, especially in vulnerable children under 12 years of age who do not have approved therapies.
we are very pleased with today's results and are committed to working closely with the FDA to complete the review of Ryoncil's application.
" References: .S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil™) for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease. Retrieved August 14, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .