Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company's New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world's first approved stem cell therapy.
Priority Review is granted when Health Canada determines that the summary clinical data provided demonstrates substantial evidence of the drug's effectiveness in treating a life-threatening condition. Priority Review candidates are subject to the same quality, safety and efficacy requirements as non-priority submissions, but are processed more quickly.
The application is the first in Osiris' global registration strategy for Prochymal. The NDS was filed in the electronic Common Technical Document (eCTD) format to facilitate review and allow for efficient submission in other territories. The submission marks the first application for full approval of a stem cell therapy anywhere in the world. Prochymal is currently available to patients with refractory acute GvHD in the United States under an expanded access program.
As part of the review, Health Canada has also informed Osiris of its plans to add Prochymal to its Register of Innovative Drugs subject to a final review upon approval. Registration confers eight years of market exclusivity beginning on the date of Prochymal's approval, during which no submission for a generic version of Prochymal will be approved.
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