US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations
Over the first five years of the regenerative medicine advanced therapy designation, analysis by the Pink Sheet finds the 40% success rate of requests is comparable to the broader breakthrough therapy designation, despite less stringent RMAT criteria.
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The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.
New RMAT Designations Include Autolous’ CAR-T, Direct Biologics’ Extracellular Vesicles And Allovir’s Antiviral T-cells
Latest regenerative medicine advanced therapy awards from US FDA address B-cell acute lymphocytic leukemia, acute respiratory distress syndrome associated with COVID-19, infection risk in stem cell transplant patients, and an ultra-rare form of severe combined immunodeficiency.
Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.