Crovalimab-akkz

(Piasky®)

Piasky®

Drug updated on 10/18/2024

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.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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