Osiris gains 2nd FDA OK for early use of Prochymal
Columbia-based Osiris Therapeutics Inc. announced yesterday that the Food and Drug Administration granted the company permission to offer its adult stem-cell therapy called Prochymal to adults with life-threatening graft-versus-host disease. The decision allows Osiris to provide the drug before general marketing begins. The disease is a deadly complication affecting about half of patients who receive bone marrow transplants each year. Under the expanded access program, experimental drugs in late-stage clinical trials are provided to patients under certain circumstances when no alternative treatment is available. Prochymal is in late-stage clinical trials as a treatment for a type of Crohn’s disease characterized by chronic intestinal inflammation, and two types of graft-versus-host disease. Last year, the FDA approved Prochymal for an expanded access program for pediatric patients with graft-versus-host disease. Osiris shares rose 87 cents, or almost 5 percent, to close at $18.59 yesterday.
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