IASO Bio Reports the US FDA’s IND Approval of Equecabtagene Autoleucel for Two New Autoimmune Diseases
Shots:
- The US FDA has cleared the IND application of Equecabtagene Autoleucel (Eque-cel) as a treatment of non-renal systemic lupus erythematosus (SLE) & lupus nephritis (LN)
- Eque-cel has previously obtained 3 IND approvals from the US FDA for autoimmune conditions (MG, MS, SLE/LN) & 2 from the NMPA for NMOSD & MG. It was also approved by the NMPA in Jun 2023 to treat r/r multiple myeloma after multiple prior therapies
- Eque-cel is a BCMA-targeted CAR T-cell therapy developed to eliminate BCMA-expressing cells. It reduces pathogenic cells & autoantibodies in SLE patients, suppressing autoimmune inflammation. Studies in China have shown its efficacy & safety in treating r/r autoantibody-mediated neurological diseases
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