Drug news
Health Canada approves Prochymal (Osiris Therapeutics) for Graft-v-Host Disease in children
Canadian health regulators have approved Prochymal, from Osiris Therapeutics, for acute Graft-v-Host Disease in children who are not responding to steroid therapy, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.