Osiris' Prochymal Becomes World's First Approved Stem Cell Drug
Prochymal has become the world's first approved stem cell drug.
Health Canada has issued marketing authorisation for Prochymal (remestemcel-L), making Osiris Therapeutics' intravenous therapy the first manufactured stem cell product to be approved in the world.
Prochymal is designed to treat acute paediatric graft-vs-host disease (GvHD) - a life-threatening complication where immune cells in transplanted bone marrow mount an immunologic attack, leading to death in up to four-fifths of cases.
It consists of an intravenous infusion of mesenchymal stem cells derived from the bone marrow of healthy adult donors.
Health Canada's decision means Prochymal is now available in eight countries, including the US, under an expanded access programme.
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