FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
Abatacept
DrugDrug Profile
Abatacept is a selective T-cell co-stimulation modulator used for autoimmune and immune-mediated conditions including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and prophylaxis of acute graft-versus-host disease.
- Drug Class
- Selective T-cell costimulation modulator (biologic DMARD)
- Approval Status
- FDA approved (initial U.S. approval: 2005; aGVHD prophylaxis indication added December 15, 2021)
- Mechanism of Action
- Binds CD80/CD86 on antigen-presenting cells and blocks CD28-mediated T-cell costimulation
- Orencia
- \Moderately to severely active rheumatoid arthritis\
- \Active psoriatic arthritis\
- \Active polyarticular juvenile idiopathic arthritis\
- \Prophylaxis of acute graft-versus-host disease with CNI and methotrexate in eligible HSCT patients\
Related News
Dr. Reddy's says FDA accepted abatacept biosimilar BLA for review
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Novel GVHD Prevention Regimen Shows Strong Results Without Standard Immunosuppressants
Interim results from the ABC phase 1/2b trial show a calcineurin inhibitor-free GVHD prevention regimen combining posttransplant cyclophosphamide, bortezomib, and abatacept achieved low GVHD rates and favorable survival outcomes. The approach enables earlier introduction of posttransplant maintenance therapies while reducing toxicity associated with conventional immunosuppressants.
Coya Therapeutics Advances ALS Combo Immunotherapy Into Phase 2 Trial
Coya Therapeutics detailed plans for a Phase 2 trial of combination immunotherapy targeting neuroinflammation in ALS, following a four-patient study showing biomarker improvements and reported slowing of disease progression.
FDA Accepts NDAs for Beren's Adrabetadex and Dr. Reddy's Abatacept Biosimilar
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
Dr. Reddy's Gains FDA Acceptance for First Abatacept Biosimilar in U.S.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
FDA Accepts Dr Reddy's Application for Orencia Biosimilar DRL-AB
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
FDA Accepts Dr. Reddy's BLA for Proposed Interchangeable Abatacept Biosimilar
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
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