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  • More treatment options for PNH¡¦entry of 'Piasky' imminent
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Jun 4, 2025 06:19am
MFDS is conducting the final review¡¦'Piasky' is expected to be commercialized in the second half of this year
'Fabhalta' entered drug price negotiations¡¦anticipated to be included to the reimbursement list
The entry 'Piasky,' a new PNH drug, into the Korean market is imminent.

According to industry sources, Roche Korea's Piasky (crovalimab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is undergoing final review for approval by the Ministry of Food and Drug Safety (MFDS). It is expected to be officially approved in the second half of this year.

Piasky received the U.S. Food and Drug Administration (FDA) approval in June 2024. Then, it was commercialized in Europe in August of the same year. In February 2024, 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-dos
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