To date, what number of U.S. FDA approved RMATs have been issued and to whom have they been awarded?
The answer is that 70 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 210 requests and issued 81, which means that a handful are not yet public knowledge.
Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (81 approvals / 210 applications = 38.6%).
Thus far, AlloVir and CRISPR Therapeutics are the only two companies to receive three RMATs, while six companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, and Rocket Pharmaceuticals) have received two RMAT designations from the U.S. FDA.
