• 23 May 2024
• Admin
• News Article

Chugai introduces PiaSky for injection 340 MG

Chugai introduces PiaSky for injection 340 mg, a subcutaneously administered anti-C5 antibody in Japan to treat paroxysmal nocturnal hemoglobinuria

Overview

Chugai Pharmaceutical Co., Ltd. announced that it launched PiaSky for injection 340 mg (generic name: crovalimab (genetical recombination), a pH-dependent binding humanized anti-complement (C5) monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Approvals 

PiaSky had been approved by the Ministry of Health, Labour and Welfare (MHLW) on March 26, 2024 and was listed on the national health insurance (NHI) reimbursement price list.

Words from CEO: Chugai

• “We are very pleased to launch PiaSky as a new treatment for PNH. Anti-complement C5 antibodies are a standard of care for PNH, and PiaSky has become the first subcutaneously administered medicine in the class in Japan. By decreasing the administration time, we hope to reduce the burden on patients and caregivers and minimize interruptions to their day-to-day lives,” said Chugai’s president and CEO, Dr. Osamu Okuda. 
• “This is the fifth launch in Japan of a Chugai originated antibody medicine. Japan is the first country in which PiaSky is launched, and the medicine is also under review for approval in PNH in the United States and Europe. Through our company’s technology-driven drug discovery strategy, Chugai will further advance research and development to continuously provide new value to patients affected by various diseases.”

Recycling Antibody Technology

• 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).

This approval was based mainly on the results of the COMMODORE 2 study in patients with PNH who were naïve 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 Japan is also participating.

PiaSky: Anti-C5 Recycling Antibody

• PiaSky 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 Asia (appears in approximately 3.2% of Japanese patients with PNH), which causes existing antibody drugs not to bind to C5.

PiaSky Approval in China

• PiaSky has been approved in China in February 2024, for the treatment of adults and adolescents (12 years of age and above) with PNH who have not been previously treated with complement inhibitors, as Chugai’s fifth global drug. 
• Also, it is under review by other regulatory authorities, including in the US, EU, and Taiwan. 
• In addition, clinical trials are ongoing for atypical hemolytic uremic syndrome (aHUS), and Roche is conducting trials for sickle cell disease (SCD) overseas.

Paroxysmal Nocturnal Hemoglobinuria

• Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hematopoietic stem cell disorder characterized by intravascular haemolysis due to complement activation. 
• It is caused by the clonal expansion of hematopoietic stem cells, driven by acquired mutations in the PIG-A gene. 
• While symptoms may vary in each individual, there are typically two types. 
• One is symptoms attributed to the characteristic haemolysis in PNH, such as hemoglobinuria and thrombosis. 
• The other is hematopoietic failures similar to those associated with aplastic anaemia. PNH may cause complications, including chronic kidney disease and pulmonary hypertension. 
• In Japan, PNH is a rare disease that is listed as one of the designated intractable diseases (designated intractable disease 62). 
• 1,035 individuals have been granted the medical care recipient certificate for PNH as of the end of FY2022.