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  • Roche's new PNH drug 'Piasky' expected to be launched in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Dec 6, 2024 05:56am
In February, Piasky received an orphan drug designation from the MFDS in KOR
Demonstrated to be non-inferior to Soliris, based on a direct comparison study
A new PNH drug, 'Piasky,' is expected to be launched in South Korea.

According to industry sources, Roche Korea is currently undergoing the approval review process for Piasky (crovalimab), a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH).

This drug received the U.S. Food and Drug Administration (FDA) approval in June. In August, it was commercialized in Europe. In February Piasky was designated as an orphan drug in South Korea.

Discovered by Japan's Chugai Pharmaceutical and developed by Roche, crovalimab is a type of new anti-complement (C5) antibody. Low-dose subcutaneous administration every four weeks enables circulation of the drug in the blood, thereby repeatedly inhibiting the complement.

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