The Biologics and Genetic Therapies Directorate of Health Canada has granted priority review status to Osiris Therapeutics’ Prochymal, a stem cell-based treatment for graft-versus-host disease.

Priority review is granted when there is substantial evidence of the drug’s effectiveness in treating a life-threatening condition and shortens the examination period from 300 to 180 days.

The submission marks the first application for full approval of a stem cell therapy anywhere in the world.

Prochymal is currently available for refractory acute graft-versus-host disease in the US under an expanded access programme.