Roche’s PiaSky wins US approval for PNH

24 June 2024

The US Food and Drug Administration (FDA) has approved Roche's (ROG: SIX) PiaSky (crovalimab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

This approval is based on a late-stage study on PiaSky—which is administered either monthly via an under-the-skin injection or intravenously.

The results showed that Roche's drug achieved a 79.3% control rate in preventing the destruction of red blood cells, compared to 79% with current standard-of-care treatment, eculizumab, over a period from week 5 to week 25.

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