Osiris Therapeutics Announces the World's First Approval of a Stem Cell Therapy - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Osiris Therapeutics Announces the World's First Approval of a Stem Cell Therapy


ePT--the Electronic Newsletter of Pharmaceutical Technology

Osiris Therapeutics announced that it received marketing authorization from Health Canada to market its stem-cell therapy, Prochymal (remestemcel-L), for the treatment of graft-versus-host disease in children who fail to respond to steroids. Prochymal is a manufactured mesenchymal stem cell therapy derived from the bone marrow of healthy adult donors.

According to the company press release, Health Canada’s marketing authorization marks the world’s first approval of a manufactured stem-cell product, and the first approved treatment for graft-versus-host disease. The product was approved under Health Canada’s Notice of Compliance with conditions pathway, which is an accelerated approval pathway for products that address unmet medical conditions and which have shown a favorable risk/benefit profile in clinical trials. Under this pathway, further clinical trials will be required to verify the anticipated benefit.

Graft-versus-host disease is a complication resulting from bone marrow transplantation in which immune cells contained in the transplant recognize the recipient of the graft as foreign and mount an immune response. Severe graft-versus-host disease is fatal in as much as 80% of cases. Steroids are the first-line treatment, but have a success rate of only 30–50%. According to the company website, Prochymal is currently in Phase III trials in the US for treatment of graft-versus-host disease and Crohn’s disease and has been awarded both Orphan Drug and fast track status from FDA.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here