Osiris (OSIR) Wins Marketing Clearance for Prochymal from Health Canada
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Osiris Therapeutics Inc. (NASDAQ: OSIR) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal® (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the world’s first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD — a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.
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.
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.
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