Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement
Shots:
- The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement
- Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) will start in Q1’25, with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) enrollment expected in H2’25
- The P-I (GLEAN) trial demonstrated robust exposure and complete CD19+ B-cell depletion as ADI-001 targets B-cells via an anti-CD20 CAR
Ref: Businesswire | Image: Adicet Bio
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
