The therapy is for people with severe and moderately severe hemophilia B.
The therapy in trial is for the prophylactic treatment of individuals with hemophilia A or B with inhibitors.
The company reported on preliminary data from the Phase 1/2 clinical trial designed to evaluate SB-525, the company’s gene therapy program for people with hemophilia A.
The therapy is administered via a one-time intravenous infusion, which is designed to elicit the production of therapeutic levels of factor VIII.
The preliminary injunction was part of an ongoing patent lawsuit.
The first stage will collect data that will be eventually used to evaluate the efficacy and safety of the investigational hemophilia B therapy.
The update reported on a Phase 1/2 clinical trial for the company’s investigational therapy for the treatment of patients with severe hemophilia B/factor IX (FIX) deficiency.
The new web portal for patients and caregivers is intended to provide timely and accurate information on targeted serious adverse events of interest for HEMLIBRA.
This priority review is specifically for adults and children with hemophilia A without FVIII inhibitors.
The new vial size is 3500 IU (international unit).
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