Chemistry:Crovalimab

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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][2]

Crovalimab was approved for use in China in February 2024,[3] in Japan in April 2024,[4] in the United States in June 2024,[5][6] and in the European Union in August 2024.[7][8] It was developed and is marketed by Roche/Genentech.[citation needed]

Medical uses

In the US, crovalimab is indicated for the treatment of people aged 13 years of age and older with paroxysmal nocturnal hemoglobinuria and body weight of at least 40 kilograms (88 lb).[1][9]

Adverse effects

The US Food and Drug Administration (FDA) label for crovalimab contains a boxed warning about the increased risk of Neisseria meningitidis infection, which can be life-threatening.[1]

History

Clinical trials

Three phase III clinical trials have evaluated crovalimab in both people who were C5 inhibitor–naive and those switching to crovalimab from other C5 inhibitors.[10]

COMMODORE 1[11] is a phase III randomized clinical trial comparing crovalimab vs eculizumab in people with paroxysmal nocturnal hemoglobinuria treated with C5 inhibitors.[12] COMMODORE 1 examines the safety, tolerability and pharmacokinetic/pharmacodynamic properties of crovalimab in PNH patients switching from eculizumab. The study showed that crovalimab maintained disease control in PNH patients switching from eculizumab.[12][13]

COMMODORE 2[14] is a phase III randomized trial comparing crovalimab vs eculizumab in people with paroxysmal nocturnal hemoglobinuria who are naive to C5 inhibitor treatment.[15] COMMODORE 2 was positive for its co-primary endpoints, transfusion avoidance and hemolysis control (measured lactate dehydrogenase levels) which are disease control indicators, and its data shows crovalimab is non-inferior to eculizumab.[16][15][17][18]

COMMODORE 3[19] is a phase III single-arm trial run in China, studying crovalimab in C5 inhibitor-naive people with paroxysmal nocturnal hemoglobinuria.[20] COMMODORE 3 assessed the safety, efficacy, pharmacokinetics, and pharmacodynamics of crovalimab in people with C5-naive paroxysmal nocturnal hemoglobinuria. The study met the co-primary efficacy endpoints of haemolysis control and transfusion avoidance.[20][21]

Society and culture

Crovalimab was approved for use in China in February 2024,[3] and in Japan in April 2024.[4][22]

Crovalimab was approved for medical use in the United States in June 2024.[5][9]

In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Piasky, intended as monotherapy for the treatment of people twelve years of age or older with a weight of 40 kilograms (88 lb) and above with paroxysmal nocturnal haemoglobinuria.[7][23] The applicant for this medicinal product is Roche Registration GmbH.[7] Crovalimab was authorized for medical use in the European Union in August 2024.[7][8]

Names

Crovalimab is the international nonproprietary name.[24]

Research

Crovalimab is the subject of five phase III studies for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS). It is also being investigated for the treatment of sickle cell disease and other conditions.[25]

References

  1. ↑ 1.0 1.1 1.2 1.3 "Piasky- crovalimab injection, solution". 28 June 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2597efc2-a97b-487c-b500-a67fd282a73b. 
  2. ↑ Röth, Alexander; Nishimura, Jun-ichi; Nagy, Zsolt; Gaàl-Weisinger, Julia; Panse, Jens; Yoon, Sung-Soo; Egyed, Miklos; Ichikawa, Satoshi et al. (19 March 2020). "The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria". Blood 135 (12): 912–920. doi:10.1182/blood.2019003399. PMID 31978221. 
  3. ↑ 3.0 3.1 "Crovalimab Approved in China as the First Country, for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)". 8 February 2024. https://www.chugai-pharm.co.jp/english/news/detail/20240208113000_1047.html. 
  4. ↑ 4.0 4.1 "Japan Becomes Second Market to Approve Roche's Piasky". 3 April 2024. https://www.navlindaily.com/article/21186/japan-becomes-second-market-to-approve-roche-s-piasky. 
  5. ↑ 5.0 5.1 "Novel Drug Approvals for 2024". 21 June 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024. 
  6. ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025. 
  7. ↑ 7.0 7.1 7.2 7.3 "Piasky EPAR". 27 June 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/piasky.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ↑ 8.0 8.1 "Piasky Product information". 26 August 2024. https://ec.europa.eu/health/documents/community-register/html/h1848.htm. 
  9. ↑ 9.0 9.1 "Crovalimab approval letter". https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761388Orig1s000ltr.pdf.  Public Domain This article incorporates text from this source, which is in the public domain.
  10. ↑ "A complementary new drug for PNH". Blood 135 (12): 884–885. March 2020. doi:10.1182/blood.2020004959. PMID 32191798. 
  11. ↑ A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors (Report). 6 June 2024. https://clinicaltrials.gov/study/NCT04432584. Retrieved 21 June 2024. 
  12. ↑ 12.0 12.1 Scheinberg, Phillip; Cle, Diego; Edwards, John; Giai, Valentina; Hus, Marek; Kim, Jin Seok; Lekue, Cristina Barrenetxea; Nagy, Zsolt et al. (8 August 2023). "S183: Phase III Randomized, Multicenter, Open-Label COMMODORE 1 Trial: Comparison of Crovalimab vs Eculizumab in Complement Inhibitor-Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)". HemaSphere 7 (S3): e45540d8. doi:10.1097/01.HS9.0000967644.45540.d8. 
  13. ↑ "The phase III randomized, multicenter COMMODORE 1 trial: comparison of crovalimab vs eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH)". 26 October 2023. https://medically.gene.com/global/en/unrestricted/haematology/AAMDSIF-2023/aamdsif-2023-poster-scheinberg-the-phase-iii-randomized.html. 
  14. ↑ A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors (Report). 15 May 2024. https://clinicaltrials.gov/study/NCT04434092. Retrieved 21 June 2024. 
  15. ↑ 15.0 15.1 "Lens extraction with ultrasound. Experiments in rabbits". The British Journal of Ophthalmology 60 (11): 759–64. November 1976. doi:10.1136/bjo.60.11.759. PMID 1009054. 
  16. ↑ Kulasekararaj, Austin; He, Guangsheng; Munir, Talha; Pu, Jeffrey; Risitano, Antonio; Röth, Alexander; Sima, Camelia S.; Appius, Anita et al. (5 November 2020). "Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with Complement Inhibitors". Blood 136 (Supplement 1): 34. doi:10.1182/blood-2020-136647. 
  17. ↑ "The phase III, randomized COMMODORE 2 trial: results from a multicenter study of crovalimab vs eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients naive to complement inhibitors". 9 June 2023. https://medically.gene.com/global/en/unrestricted/haematology/EHA-2023/eha-2023-presentation-roth-the-phase-iii-randomized-com.html. 
  18. ↑ "Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition". American Journal of Hematology 99 (9): 1768–1777. June 2024. doi:10.1002/ajh.27412. PMID 38884175. 
  19. ↑ A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition (Report). 31 May 2024. https://clinicaltrials.gov/study/NCT04654468. Retrieved 21 June 2024. 
  20. ↑ 20.0 20.1 Liu, Hui; Xia, Linghui; Weng, Jianyu; Zhang, Fengkui; He, Chuan; Gao, Sujun; Jia, Jinsong; Chang, Alice C. et al. (15 November 2022). "Results from the First Phase 3 Crovalimab (C5 Inhibitor) Study (COMMODORE 3): Efficacy and Safety in Complement Inhibitor-Naive Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)". Blood 140 (Supplement 1): 714–716. doi:10.1182/blood-2022-162452. 
  21. ↑ "Six-Month Crovalimab Extension in the Phase III COMMODORE 3 Study: Updated Efficacy and Safety Results in Complement Inhibitor-Naive Patients with Paroxysmal Nocturnal Hemoglobinuria". 9 June 2023. https://medically.gene.com/global/en/unrestricted/haematology/EHA-2023/eha-2023-poster-alice-six-month-crovalimab-extension-in.html. 
  22. ↑ "Crovalimab: First Approval". Drugs 84 (6): 707–716. May 2024. doi:10.1007/s40265-024-02032-5. PMID 38740735. https://figshare.com/articles/online_resource/Crovalimab_First_Approval/25468003. 
  23. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". 28 June 2024. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024. 
  24. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information 33 (1). 2019. 
  25. ↑ "Genentech Announces Positive Data From Global Phase III Program for Crovalimab in PNH, a Rare, Life-Threatening Blood Condition". Genentech (Press release). 6 February 2023. Archived from the original on 12 January 2024. Retrieved 13 January 2024.



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