As F.
The approval is based on the results of several studies including COMMODORE 3 study, a multicenter, single-arm, phase III clinical trial conducted in
Crovalimab has been created using Chugai s Recycling Antibody technology. While a typical antibody can bind to an antigen only once, crovalimab is engineered to bind to the antigen repeatedly, enabling sustained complement inhibition at a low dose and achieving subcutaneous administration every four weeks. Crovalimab is the second approved drug applying Chugai s Recycling Antibody technology, following Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
About Crovalimab
Crovalimab (genetical recombination) is an anti-C5 recycling antibody created with Chugai s Recycling Antibody technology. Recycling antibodies are designed to achieve pH-dependent antigen binding so that a single antibody molecule can bind with the antigen multiple times, enabling a longer efficacy compared with a conventional antibody. Crovalimab is designed to target C5, a key component of the complement system, and is expected to control complement activity. It is also expected to reduce the treatment burden for patients and their caregivers through subcutaneous administration. Since crovalimab binds to complement C5 at a different site from existing antibody drugs, it can be an effective treatment option for patients with a specific C5 gene mutation reported in
The drug has been filed for approval as a new drug for PNH in
About paroxysmal nocturnal hemoglobinuria
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hematopoietic stem cell disorder characterized by intravascular hemolysis due to complement activation. It is caused by the clonal expansion of hematopoietic stem cells, driven by acquired mutations in the PIG-A gene.3 While symptoms may vary in each individual, there are typically two types. One is symptoms attributed to the characteristic hemolysis in PNH, such as hemoglobinuria and thrombosis. The other is hematopoietic failures similar to those associated with aplastic anemia. PNH may cause complications, including chronic kidney disease and pulmonary hypertension.
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
Tel: +81-3-3273-0554
Email: ir@chugai-pharm.co.jp
(C) 2024 Electronic News Publishing, source