Summary basis of decision (SBD) for Prochymal®

Health Canada has issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Guidance to Osiris Therapeutics, Inc., for the drug product Prochymal. The product was authorized under the NOC/c Guidance on the basis of the promising nature of the clinical evidence, and the need for confirmatory studies to verify the clinical benefit. Patients should be advised of the fact that the market authorization was issued with conditions. Prochymal [remestemcel-L, adult human mesenchymal stem cells (hMSCs) for intravenous infusion] is a liquid cell suspension of ex vivo cultured adult hMSCs. The hMSCs are derived from the bone marrow of unrelated and human leukocyte antigen (HLA)-unmatched healthy adult donors. Prochymal is indicated in the management of acute Graft versus Host Disease (aGvHD) in paediatric patients. Read more here.