To date, 46 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 146 requests and issued 52.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
The most recent addition to this list was the RMAT awarded to Athersys for use of MultiStem product in the treatment of ARSD. Prior to that it was Medeor Therapeutics for its cell therapy, MDR-101. Thus far, only two companies (Abeona Therapeutics and Athersys) have received two RMAT awards from the U.S. FDA.
