Crovalimab — Drug Monograph

Brand names: Piasky

Drug class: Monoclonal Antibody

Mechanism of Action

Crovalimab is a humanized, recycling anti-C5 monoclonal antibody engineered with pH-dependent antigen binding (Sequential Monoclonal Antibody Recycling Technology) so that it releases C5 in the acidic endosome and returns to the circulation to bind additional C5 molecules. Like other C5 inhibitors, it binds complement C5 and prevents its cleavage into C5a and C5b, blocking terminal complement activation and formation of the membrane attack complex (C5b-9), thereby stopping intravascular hemolysis in PNH. The recycling mechanism plus a small volume permits low-volume subcutaneous dosing every…

FDA Indications

• Paroxysmal nocturnal hemoglobinuria (PNH) in adults and pediatric patients 13 years and older weighing at least 40 kg (approved June 2024)

Common Side Effects

• Infusion-related reactions
• Injection site reactions
• Upper respiratory tract infection
• Headache
• Nasopharyngitis
• Pyrexia
• Fatigue
• Diarrhea
• Nausea

Clinical Pearl

In the COMMODORE 1, 2, and 3 trials, crovalimab was non-inferior to eculizumab for hemolysis control while allowing low-volume subcutaneous self-administration only once every 4 weeks, a major convenience advantage. Because circulating drug-target-drug complexes can form during switching between C5 inhibitors, clinicians should follow the labeled washout/transition guidance and watch for transient type III hypersensitivity reactions.

Related Therapies & Mechanisms

• Eculizumab (Soliris) — Monoclonal Antibody · PNH
• Ravulizumab (Ultomiris) — Monoclonal Antibody · PNH
• Alemtuzumab (Campath) — Monoclonal Antibody
• Amivantamab (Rybrevant) — Monoclonal Antibody