Piasky was approved in
'We are very pleased that Piasky, a Chugai originated drug, has now been approved in
This approval was based mainly on the results of the COMMODORE 2 study in patients with PNH who were naive to C5 inhibitors and the COMMODORE 1 study in patients with PNH who switched to crovalimab from previously approved C5 inhibitors. Both are global phase III studies in collaboration with Roche, and
Piasky uses Chugai's Recycling Antibody technology. Unlike conventional antibodies that bind to an antigen only once, crovalimab has been engineered to bind to the antigen repeatedly, enabling low dose subcutaneous administration every four weeks. This is the second approval for a drug using the recycling antibody technology following Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
Approval Information
Product name: PIASKY for Injection 340 mg
Generic name: crovalimab (genetical recombination)
Indications: Paroxysmal nocturnal hemoglobinuria
Dosage and administration
The usual Day 1 dose is 1000 or 1500 mg of crovalimab (genetical recombination) once by intravenous infusion, and subsequently, 340 mg is subcutaneously administered once on Days 2, 8, 15, and 22, and 680 or 1020 mg is subcutaneously administered once every 4 weeks from Day 29 onward, taking the patient's body weight into account.
About Piasky
Pisaky 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
Piasky has been approved 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. In
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
Tel: +81-3-3273-0554
Email: ir@chugai-pharm.co.jp
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