Last reviewed 2026-04-23 · How we verify

MEDI-546

MEDI-546 is a monoclonal antibody that targets and inhibits B-cell activating factor (BAFF) to reduce B-cell proliferation and autoimmune responses.

MEDI-546 is a monoclonal antibody that targets and inhibits B-cell activating factor (BAFF) to reduce B-cell proliferation and autoimmune responses. Used for Systemic lupus erythematosus (SLE), Rheumatoid arthritis.

At a glance

Mechanism of action

MEDI-546 binds to BAFF, a key cytokine involved in B-cell survival and activation. By neutralizing BAFF, the drug reduces the number and activity of B cells, thereby suppressing autoimmune and inflammatory responses. This mechanism is intended to treat B-cell-mediated autoimmune diseases.

Approved indications

• Systemic lupus erythematosus (SLE)
• Rheumatoid arthritis

Common side effects

• Infection
• Nasopharyngitis
• Infusion reactions

Key clinical trials

• Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (PHASE3)
• An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants (PHASE3)
• Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (PHASE3)
• Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE (EARLY_PHASE1)
• Anifrolumab Early Access Program
• An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults (PHASE2)
• Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus. (PHASE2)
• A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus (PHASE2)

Primary sources

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