Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 340 mg/2 mL [170 mg/mL]); Injection (subcutaneous; 340 mg/2 mL [170 mg/mL]) |
Drug Class | Complement 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
Summary
- 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 Title | Year | Source |
---|---|---|
Piasky (crovalimab-akkz) Prescribing Information. | 2024 | Genentech, Inc., South San Francisco, CA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria | Data not availableSubjects F: null% M: null% | 2024 | American Journal of Hematology |
Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition | Data not availableSubjects F: null% M: null% | 2024 | American Journal of Hematology |
Sex Distribution:
Year:
2024
Source:American Journal of Hematology
Sex Distribution:
Year:
2024
Source:American Journal of Hematology