Regulatory Focus™ > News Articles > Health Canada Approves World's First Stem Cell-Based Therapy

Health Canada Approves World's First Stem Cell-Based Therapy

Posted 21 May 2012 | By Alexander Gaffney, RAC 

Canadian regulators have approved the world's first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics' Prochymal approval for the treatment of graft-versus-host disease (GVHD).

GVHD affects patients who have undergone a bone marrow transplant, and results in the transplanted cells attacking the host's own cells.

Osiris' Prochymal uses stem cells extracted from the bone marrow of adults, side-stepping ethical issues inherent in using stem cells from human embryos, notes The New York Times.

While steroid-based therapies continue to be a first-line treatment for GVHD, Prochymal was approved by Health Canada to treat children suffering from GVHD who did not exhibit a favorable response to steroid-based therapy. Of the children enrolled in a clinical trial for GVHD, approximately 60% had a favorable response to the treatment after not responding well to steroids-a huge improvement in a disease known to kill up 80% of affected patients, explains Reuters and The New York Times.

The drug is likely to face US Food and Drug Administration regulators later in 2012. Osiris said it delayed seeking US approval after regulators said they would need additional data before granting approval, causing it to seek approval in Canada first, writes InPharm.

Read more:

The New York Times - A Stem-Cell-Based Drug Gets Approval in Canada

Reuters - Canada OKs Osiris drug; first stem cell therapy

InPharm - World's first stem cell drug approved in Canada

Osiris Therapeutics - Prochymal

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