Osiris Prochymal Wins Even More FDA Approval

Thursday, Columbia-based stem cell therapeutic company, Osiris Therapeutics Inc. , said that it has received clearance from the U.S. Food and Drug Administration, or FDA, to broaden its expanded access program for Prochymal, thereby making the investigational stem cell product available to adults with life-threatening Graft vs. Host Disease or GvHD.Prochymal is currently in its Phase III clinical trials for GvHD and Crohn's disease. Expanded access to Prochymal was initially restricted to only pediatric patients suffering from steroid refractory GvHD until patient enrollment in the Phase III pivotal trial was completed.

Osiris noted that under the expanded access program, patients from two months to 70 years of age, inclusive, who have been diagnosed with GvHD that is unresponsive to steroid therapy, are eligible to receive Prochymal. Additionally, for expanded access, the FDA must determine that the available scientific evidence, taken as a whole, demonstrates that the drug may be effective and would not expose the patients to unreasonable risks.