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Chugai's PiaSky® Receives European Approval for Treatment of PNH

03 Sep 2024
Admin
News Article

Chugai's PiaSky® Receives European Approval for Treatment of PNH

Overview

Chugai Pharmaceutical has announced that the European Commission has granted approval for PiaSky® (crovalimab), a Chugai-developed monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents aged 12 and over, who weigh at least 40 kg.

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare blood disorder caused by mutations in the PIG-A gene, leading to the destruction of red blood cells by the immune system.

The condition can cause a range of symptoms, including severe anaemia, blood in the urine, and an increased risk of blood clots.

Associated Complications

PNH is associated with complications such as chronic kidney disease and pulmonary hypertension.
In Japan, PNH is recognized as a designated intractable disease, with 1,035 patients receiving medical care as of the end of FY2022.

About PiaSky

PiaSky is a novel anti-C5 recycling antibody developed by Chugai using their proprietary technology.
This antibody can bind to the C5 protein multiple times, allowing for a longer duration of action with a lower dosage compared to conventional antibodies.

Advantage of PiaSky

Designed to be administered subcutaneously every four weeks, PiaSky offers a more convenient treatment option for patients with PNH, potentially reducing the burden on patients and caregivers alike.

This approval covers patients new to treatment as well as those previously treated with C5 inhibitors.

PNH: Symptoms

PNH is a rare, life-threatening blood disorder where the body's immune system mistakenly attacks and destroys red blood cells.
This can lead to symptoms like anaemia, fatigue, blood clots, and potentially cause kidney damage.

Behind the Design & Function of PiaSky

PiaSky, designed using proprietary Recycling Antibody® technology, allows for a smaller dosage and less frequent administration, with monthly subcutaneous injections during the maintenance phase.
We believe that PiaSky, which can be self-administered with proper training, will greatly ease the treatment burden for those with PNH.""

PiaSky: Approval by EU

PiaSky is the first monthly subcutaneous treatment for PNH approved in the European Union.
The medication’s design aims to reduce the impact of ongoing treatment on patients' daily lives, offering an option for self-administration after appropriate training.

Phase III COMMODORE 2 Study

The approval was based on results from the Phase III COMMODORE 2 study, which involved patients with PNH who had not previously received C5 inhibitors.
The study found that monthly subcutaneous injections of PiaSky provided effective disease control and were well-tolerated.

Results

The efficacy of PiaSky was shown to be non-inferior to that of eculizumab, a standard C5 inhibitor administered intravenously every two weeks.
The occurrence of adverse events was comparable between the two treatments, with rates of 78% for PiaSky and 80% for eculizumab.
Additional data from two other Phase III studies, COMMODORE 1 and COMMODORE 3, further supported the application for approval.

PiaSky: Previous Approvals

PiaSky, which has already received approval in the US, Japan, and China, is being studied in a broad clinical development programme.
This includes five Phase III studies and several earlier phase studies, exploring its use in other complement-mediated diseases such as atypical haemolytic uremic syndrome and sickle cell disease.

The approval of PiaSky also includes its use in patients with specific C5 gene mutations common in Asia, for whom existing treatments may be less effective. PiaSky has already been approved in China, Japan, and the US and is under review in other countries, including Taiwan. Additionally, clinical trials are ongoing for its potential use in other diseases, such as atypical haemolytic uremic syndrome and sickle cell disease.