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The safety and effectiveness of etranacogene dezaparvovec were evaluated by the US Food and Drug Administration (FDA) in two studies of 57 adult men 18 to 75 years of age with severe or moderately severe hemophilia B. [7] Effectiveness was established based on decreases in the men's annualized bleeding rate (ABR). [7]
In the US, fidanacogene elaparvovec is indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy; or have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes; and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var ...
B-cell cancers Tacatuzumab tetraxetan: AFP-Cide: mab: humanized: alpha-fetoprotein: cancer Tadocizumab [101] Fab: humanized: integrin α IIb β 3: percutaneous coronary intervention: Tafasitamab [47] Monjuvi: mab: humanized (from mouse) CD19: Y: relapsed or refractory diffuse large B-cell lymphoma Talacotuzumab [26] mab: humanized: CD123 ...
Beqvez is a one-time treatment designed to enable hemophilia B patients to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that ...
(Reuters) -Australian drugmaker CSL Ltd on Tuesday set the list price of its one-time gene therapy for hemophilia B at $3.5 million, making it the world's most expensive treatment, following its ...
Questcor, a biopharmaceutical company, focuses on the treatment of patients with "serious, difficult-to-treat autoimmune and inflammatory disorders". Its primary product is FDA-approved Acthar, an injectable drug that is used for the treatment of 19 indications. [91]
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