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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here