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FDA Medication Tracker

← All approvals · Heart & blood · 2025

Qfitlia (fitusiran)

The FDA approved Qfitlia (fitusiran) on March 28, 2025 to prevent or reduce the frequency of bleeding episodes in hemophilia A or B.
Brand name
Qfitlia
Generic name
fitusiran
FDA approval date
March 28, 2025
Approved use (FDA wording)
To prevent or reduce the frequency of bleeding episodes in hemophilia A or B
Company
Genzyme Corp
Application
NDA219019
Dosage form / route
SOLUTION · SUBCUTANEOUS
Drug class (EPC)
Antithrombin-directed RNA Interaction [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Heart & blood

Indications and usage, from the FDA label

QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. ( 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.