Last reviewed 2026-04-20 · How we verify

Enjaymo (SUTIMLIMAB)

Enjaymo works by blocking the activity of the complement C1s subcomponent, a part of the immune system that can mistakenly attack red blood cells.

At a glance

Mechanism of action

Sutimlimab-jome is an immunoglobulin (IgG), subclass (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, subcomponent (C1s), serine protease which cleaves C4. Sutimlimab-jome does not inhibit the lectin and alternative pathways. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD.

Approved indications

• Cold autoimmune hemolytic anemia

Common side effects

• Respiratory tract infection
• Viral infection
• Diarrhea
• Dyspepsia
• Cough
• Arthralgia
• Arthritis
• Peripheral edema
• Urinary tract infection
• Bacterial infection
• Cyanosis
• Systemic hypertension

Key clinical trials

• Cold Agglutinin Disease Real World Evidence Registry
• Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan (PHASE3)
• A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (PHASE3)
• A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) (PHASE3)

Patents

Primary sources

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