Crovalimab-akkz

(Piasky®)

Piasky®

Drug updated on 10/17/2024

Dosage FormInjection (intravenous; 340 mg/2 mL [170 mg/mL]); Injection (subcutaneous; 340 mg/2 mL [170 mg/mL])
Drug ClassComplement C5 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.

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Summary
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  • This summary is based on the review of two randomized controlled trial(s). [1-2]
  • COMMODORE 1 (C5 Inhibitor-Experienced Patients): Crovalimab was effective in transfusion avoidance, hemolysis control, and hemoglobin stabilization, with 85% of patients preferring it over eculizumab. Improvement in fatigue levels was also noted.
  • COMMODORE 2 (C5 Inhibitor-Naive Patients): Crovalimab was non-inferior to eculizumab for hemolysis control (79.3% vs. 79.0%) and transfusion avoidance (65.7% vs. 68.1%). It showed a lower incidence of breakthrough hemolysis compared to eculizumab (10.4% vs. 14.5%).
  • In the COMMODORE 1 study, adverse events (AEs) occurred in 77% of crovalimab-treated patients and 67% of eculizumab-treated patients, with no AEs leading to treatment withdrawal or death. Type III hypersensitivity events were reported in 16% of crovalimab patients, were mild/moderate, and resolved without treatment modification. No meningococcal infections were reported.
  • In the COMMODORE 2 study, the safety profiles of crovalimab and eculizumab were similar, with no reported meningococcal infections.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Piasky (crovalimab-akkz) Prescribing Information.2024Genentech, Inc., South San Francisco, CA

Randomized Controlled Trials