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FDA Medication Tracker

← All approvals · Heart & blood · 2024

Piasky (crovalimab-akkz)

The FDA approved Piasky (crovalimab-akkz) on June 20, 2024 to treat paroxysmal nocturnal hemoglobinuria.
Brand name
Piasky
Generic name
crovalimab-akkz
FDA approval date
June 20, 2024
Approved use (FDA wording)
To treat paroxysmal nocturnal hemoglobinuria
Company
Genentech Inc.
Application
BLA761388
Dosage form / route
INJECTABLE · INTRAVENOUS
Drug class (EPC)
Complement C5 Inhibitor [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Heart & blood

Indications and usage, from the FDA label

PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. PIASKY is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.