Fate Therapeutics, Inc. (FATE), Monday announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy or RMAT designation to FT819, its off-the-shelf, iPSC-derived CAR T-cell therapy currently in Phase 1 clinical development for the treatment of moderate to severe systemic lupus erythematosus or SLE, including lupus nephritis.
Fate Therapeutics said the RMAT designation recognizes the potential of FT819 to address a significant unmet need in lupus care and provides enhanced regulatory support through increased interaction with the FDA during development.
The designation was granted based on initial safety and activity data from the company's ongoing multi-center Phase 1 clinical trial.
FT819 is the first-ever iPSC-derived CAR T-cell therapy to be evaluated in SLE.
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