Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced that Health Canada has requested additional information in support of the Company's application for approval of Prochymal, a stem cell therapy, for the treatment of graft vs. host disease (GvHD). Health Canada has determined that the application in its current form is not in full compliance with the current Canadian Food and Drug Regulations and has given Osiris 90 days to answer certain questions raised during the review. Osiris intends to fully respond to these questions within the allotted period.
"We thank the professionals at Health Canada for their rapid and thoughtful consideration of this important application," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. "We intend to work with Health Canada to expeditiously provide them the additional information necessary to complete the application and make this important therapy available to patients in need."
Last year, Prochymal was granted Priority Review by Health Canada. Priority Review candidates are subject to the same quality, safety and efficacy requirements as non-priority submissions, but are processed more quickly. If successful, Prochymal would become the world's first approved stem cell therapy.
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