Bayer received FDA approval for new extended half-life hemophilia A product for patients 12 yrs and older.
The new vial size will reduce the reconstitution time that was needed to prepare multiple vials for a similar dose.
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.
An interview with one of the recipients of NHF's Innovative Investigator Awards
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 activity will examine the technology behind the emerging approaches to gene therapy in hemophilia.
The company stated that it is their intent to provide enough advanced notice of the discontinuation to allow patients to transition to a suitable alternative therapy