Gastrointestinal bleeding cell therapy awarded Orphan Drug designation
Mesoblast (Melbourne, Australia) has been granted FDA Orphan Drug designation for Revascor (rexlemestrocel-L), their preventative therapy for post-inflammatory mucosal bleeding.
Mesoblast (Melbourne, Australia) has been granted FDA Orphan Drug designation for Revascor (rexlemestrocel-L), their preventative therapy for post-inflammatory mucosal bleeding. The treatment is intended for patients with end-stage, chronic heart failure requiring left ventricular assist device (LVAD) surgery. Revascor is an investigational cell therapy comprised of 150 million allogeneic mesenchymal precursor cells (MPCs), being developed for injection into the cardiac myocytes of patients with severe chronic heart failure. FDA Orphan Drug designation qualifies Mesoblast’s product for various benefits that should assist in the drug development process.
Silviu Itescu, Chief Executive of Mesoblast, commented: “We are very pleased that the FDA has granted our heart failure cell therapy product candidate, Revascor, Orphan Drug designation…We look forward to our upcoming meeting with the FDA to discuss a potential approval pathway under the product’s existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition”.
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