UK’s Autolus Receives RMAT Designation by FDA for CAR T Cell Therapy
London-based biopharmaceutical company, Autolus, announced that their proprietary leukemia-focused CAR T cell therapy, obecabatagene autoleucel (obe-cel), received Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. The designation comes at a pivotal time for the drug leading into a Phase 2 clinical trial. Obe-cel has already been granted Primary Medicines designation by the European Medicines Agency (EMA) and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
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