Crovalimab, sold under the brand name Piasky, is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

used for the treatment of people with

paroxysmal nocturnal hemoglobinuria Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, a part of the body's innate immune system. This destructive process ...

. It is a

complement component 5 Complement component 5 is a protein that in humans is encoded by the ''C5'' gene. Complement component 5 is involved in the complement system. It is cleaved into Complement component 5a, C5a and C5b: * Complement component 5a, C5a plays an impor ...

(C5) inhibitor. Crovalimab was approved for use in China in February 2024, in Japan in April 2024, in the United States in June 2024, and in the European Union in August 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. It was developed and is marketed by

Roche F. Hoffmann-La Roche AG, commonly known as Roche (), is a Switzerland, Swiss multinational corporation, multinational holding healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, ...

Genentech Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche. Genentech Research and Early Development operates as an independent cent ...

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 .

Adverse effects

The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) label for crovalimab contains a

boxed warning In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administratio ...

about the increased risk of ''

Neisseria meningitidis ''Neisseria meningitidis'', often referred to as the meningococcus, is a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis. The bacterium is referred to a ...

'' infection, which can be life-threatening.

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. COMMODORE 1 is a phase III randomized clinical trial comparing crovalimab vs eculizumab in people with paroxysmal nocturnal hemoglobinuria treated with C5 inhibitors. 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. COMMODORE 2 is a phase III randomized trial comparing crovalimab vs eculizumab in people with paroxysmal nocturnal hemoglobinuria who are naive to C5 inhibitor treatment. 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. COMMODORE 3 is a phase III single-arm trial run in China, studying crovalimab in C5 inhibitor-naive people with paroxysmal nocturnal hemoglobinuria. 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.

Society and culture

Legal status

Crovalimab was approved for use in China in February 2024, and in Japan in April 2024. Crovalimab was approved for medical use in the United States in June 2024. In June 2024, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

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 and above with paroxysmal nocturnal haemoglobinuria. The applicant for this medicinal product is Roche Registration GmbH. Crovalimab was authorized for medical use in the European Union in August 2024.

Names

Crovalimab is the international nonproprietary name.

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.

References

External links

* {{Authority control Monoclonal antibodies Drugs developed by Genentech Roche