Drugs / Crovalimab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed paroxysmal nocturnal hemoglobinuria 4 milestones | |||||
| Filed | US (FDA) | — | paroxysmal nocturnal hemoglobinuria | 2023-07-27 | “the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for crovalimab” chugai-pharm.co.jp ↗ “Chugai filed for approval of crovalimab for PNH simultaneously in Japan, the United States and Europe.” chugai-pharm.co.jp ↗ “Chugai’s crovalimab was filed for approval in Japan, the U.S., and Europe.” chugai-pharm.co.jp ↗ |
| Filed | EU (EMA) | — | paroxysmal nocturnal hemoglobinuria | 2023-07-27 | “Chugai filed for approval of crovalimab for PNH simultaneously in Japan, the United States and Europe.” chugai-pharm.co.jp ↗ “Chugai’s crovalimab was filed for approval in Japan, the U.S., and Europe.” chugai-pharm.co.jp ↗ |
| Filed | Japan (PMDA) | — | paroxysmal nocturnal hemoglobinuria | 2023-06-14 | “it filed regulatory applications with the Ministry of Health, Labour and Welfare for the anti-C5 antibody crovalimab” chugai-pharm.co.jp ↗ “Chugai filed for approval of crovalimab for PNH simultaneously in Japan, the United States and Europe.” chugai-pharm.co.jp ↗ “Chugai’s crovalimab was filed for approval in Japan, the U.S., and Europe.” chugai-pharm.co.jp ↗ |
| Filed | China (NMPA) | — | paroxysmal nocturnal hemoglobinuria | 2022-08-10 | “The world’s first filing for regulatory approval of our anti-C5 recycling antibody, crovalimab, was accepted in China.” chugai-pharm.co.jp ↗ “China’s NMPA accepted the world’s first filing of regulatory application for crovalimab and granted priority review” chugai-pharm.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Piasky | — | 2024-08-22 | europa.eu ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04912869 | Mar 2022 → Dec 2024 | sickle cell disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03157635 | Nov 2016 → Aug 2026 | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07172022 | Mar 2026 → Mar 2030 | antiphospholipid syndrome | Hoffmann-La Roche | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05075824 | Mar 2022 → Jun 2025 | sickle cell disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT05494619 | Nov 2022 → Mar 2026 | Guillain-Barre syndrome | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT04958265 | Nov 2021 → Jul 2025 overdue | atypical hemolytic-uremic syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04861259 | Oct 2021 → Oct 2025 overdue | atypical hemolytic-uremic syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04654468 | Mar 2021 → Feb 2022 overdue | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04434092 | Oct 2020 → Nov 2022 overdue | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04432584 | Sep 2020 → Sep 2027 expected | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-05-19 | Chugai Pharmaceutical | Regulatory PiaSky Approved in Taiwan as First Subcutaneous Treatment for Paroxysmal Nocturnal Hemoglobinuria chugai-pharm.co.jp ↗ |
| 2024-09-02 | Chugai Pharmaceutical | Regulatory PiaSky Approved in the EU as the First Monthly Subcutaneous Treatment for People with PNH chugai-pharm.co.jp ↗ |
| 2024-08-27 | Hoffmann-La Roche | Regulatory Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved PiaSky® (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria (PNH) who are either new to, or have been previously treated with C5 inhibitors. |
| 2024-08-27 | Chugai Pharmaceutical | Regulatory Roche’s Announcement regarding PiaSky (Approval in the EU for the Treatment of People with PNH) chugai-pharm.co.jp ↗
The European Commission (EC) has approved PiaSky for the treatment of adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal hemoglobinuria (PNH) |
| 2024-07-01 | Chugai Pharmaceutical | Regulatory CHMP Recommends EU approval of Chugai’s PiaSky for People with PNH chugai-pharm.co.jp ↗
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended to approve PiaSky for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), for use in adults and adolescents (12 years of age or older with a weight of 40 kg) who are either new to, or have been previously treated with C5 inhibitors. |
| 2024-06-28 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition roche.com ↗ |
| 2024-03-26 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for “Piasky 340mg” for Paroxysmal Nocturnal Hemoglobinuria in Japan chugai-pharm.co.jp ↗
This approval for not only naïve PNH but also including patients switching from previously approved C5 inhibitors, is the first in the world |
| 2024-02-08 | Chugai Pharmaceutical | Regulatory Crovalimab Approved in China as the First Country, for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) chugai-pharm.co.jp ↗
China is the first country in the world to approve crovalimab. |
| 2023-09-06 | Chugai Pharmaceutical | Regulatory FDA Accepts Application for Chugai’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). |
| 2023-06-14 | Chugai Pharmaceutical | Regulatory Chugai Files New Drug Application in Japan for Crovalimab for Paroxysmal Nocturnal Hemoglobinuria chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed regulatory applications with the Ministry of Health, Labour and Welfare for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) on June 14, 2023. |
| 2023-06-12 | Chugai Pharmaceutical | Results New Data Presented at EHA Show Chugai’s Subcutaneously Administered Crovalimab Achieved Disease Control and was Well-Tolerated in People with Paroxysmal Nocturnal Hemoglobinuria (PNH) chugai-pharm.co.jp ↗
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks (maintenance dosing) was non-inferior in disease control to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors |
| 2023-06-09 | Hoffmann-La Roche | Results New data show Roche’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH) roche.com ↗
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors1 |
| 2023-02-07 | Hoffmann-La Roche | Results Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition roche.com ↗
The study met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). |
| 2023-02-07 | Chugai Pharmaceutical | Results Chugai Announces Positive Data from Global Phase III Program for Crovalimab in PNH, a Rare Life-Threatening Blood Condition chugai-pharm.co.jp ↗
The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). |
| 2022-12-12 | Chugai Pharmaceutical | Results Roche Presents Data at American Society of Hematology (ASH) Annual Meeting chugai-pharm.co.jp ↗
Roche’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition |
| 2022-12-11 | Hoffmann-La Roche | Results Roche’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition roche.com ↗
The study met its co-primary efficacy endpoints of transfusion avoidance (TA) and haemolysis control, demonstrating that participants with PNH, who have not been treated previously with complement inhibitors and who received subcutaneous crovalimab injections every four weeks, achieved disease control. |
| 2022-11-03 | Hoffmann-La Roche | Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗
First phase III data for crovalimab show the co-primary efficacy endpoints were met, with subcutaneous injections achieving disease control in people with paroxysmal nocturnal haemoglobinuria as shown in COMMODORE 3 study in China8 |
| 2022-08-10 | Chugai Pharmaceutical | Regulatory Anti-C5 Recycling Antibody Crovalimab Obtains Priority Review in China for the Treatment of Paroxysmal Nocturnal Hemoglobinuria chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the National Medical Products Administration (NMPA) of People’s Republic of China accepted an application for regulatory approval of crovalimab (development code: SKY59/RG6107) for paroxysmal nocturnal hemoglobinuria (PNH) and granted priority review. |
All press releases naming this drug 20 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Crovalimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04434092 ↗ |
| Known as | Crovalimab-akkz | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | Piasky | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | RG-6107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | RO-7112689 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | SKY-59 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Action | Inhibit | “Crovalimab, a novel C5 inhibitor” PMID 38924124 ↗ Jun 2024 |
| Modality | Monoclonal antibody | “Crovalimab, a sequential monoclonal antibody recycling technology antibody” PMID 31978221 ↗ Mar 2020 |
| Route | Intravenous | “intravenous (IV) infusion” NCT03157635 ↗ |
| Target | C5 | “complement C5 inhibitor crovalimab” PMID 31978221 ↗ Mar 2020 |