Chugai Wins Taiwan Approval For PiaSky® To Treat PNH Based On Global COMMODORE Trial Data

Chugai Pharmaceutical announced that its subsidiary, Chugai Pharma Taiwan Ltd. (CPT), has secured an orphan drug import license from the Taiwan Food and Drug Administration (TFDA) for PiaSky®. The therapy is now approved in Taiwan for the treatment of patients aged 13 and older with paroxysmal nocturnal hemoglobinuria (PNH) who weigh at least 40 kg. CPT oversees regulatory, development, import, and sales efforts for Chugai’s products in the Taiwanese market.

“We are very pleased that Chugai-originated PiaSky has been approved in Taiwan. Paroxysmal nocturnal hemoglobinuria (PNH) is a disease with limited treatment options in Taiwan and high unmet medical needs for patients and their families. PiaSky is designed to exert sustained effects at low doses by applying Chugai’s proprietary Recycling Antibody® technology. We expect that this drug, which is the first PNH treatment in Taiwan to enable subcutaneous administration every 4 weeks during the maintenance period, will be widely useful for patients, their families, and healthcare professionals,” commented Yuji Habara, President of CPT.

The TFDA’s approval is based on data from the global Phase III COMMODORE 2 trial, which studied PiaSky in PNH patients naïve to C5 inhibitor treatment. Supporting data also came from the COMMODORE 1 trial, focused on patients switching from existing C5 inhibitors, and the COMMODORE 3 trial conducted in China, which also evaluated untreated PNH patients.