Crovalimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Complement component 5 (C5) |
| Clinical data | |
| Trade names | Piasky |
| Other names | crovalimab-akkz |
| AHFS/Drugs.com | Monograph |
| License data |
|
| Routes of administration | Subcutaneous, intravenous |
| Drug class | Complement inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6430H9974N1726O2026S46 |
| Molar mass | 145349.34 g·mol−1 |
Crovalimab, sold under the brand name Piasky, is a monoclonal antibody used for the treatment of people with paroxysmal nocturnal hemoglobinuria.[1] It is a complement component 5 (C5) inhibitor.[1][4]
Crovalimab was approved for use in China in February 2024,[5] in Japan in April 2024,[6] in the United States in June 2024,[7][8] and in the European Union in August 2024.[2][3] It was developed and is marketed by Roche/Genentech.
- ^ a b c "Piasky- crovalimab injection, solution". DailyMed. 28 June 2024. Retrieved 5 September 2024.
- ^ a b "Piasky EPAR". European Medicines Agency (EMA). 27 June 2024. Retrieved 29 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Piasky Product information". Union Register of medicinal products. 26 August 2024. Retrieved 27 August 2024.
- ^ Röth, Alexander; Nishimura, Jun-ichi; Nagy, Zsolt; Gaàl-Weisinger, Julia; Panse, Jens; Yoon, Sung-Soo; et al. (19 March 2020). "The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria". Blood. 135 (12): 912–920. doi:10.1182/blood.2019003399. PMC 7082616. PMID 31978221.
- ^ "Crovalimab Approved in China as the First Country, for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)". chugai-pharm.co.jp. 8 February 2024. Archived from the original on 18 April 2024. Retrieved 18 April 2024.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 21 June 2024. Archived from the original on 30 April 2024. Retrieved 21 June 2024.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.