Safety of PEGylated recombinant human full-length coagulation factor VIII (BAX 855) in the overall context of PEG and PEG conjugates.

ABSTRACT:

Introduction

BAX 855 is a PEGylated human full-length recombinant factor VIII (rFVIII) based on licensed rFVIII (ADVATE). The applied PEGylation technology has been optimized to retain functionality of the FVIII molecule, improve its pharmacokinetic properties and allow less frequent injections while maintaining efficacy.

Aim

The aim of this study was to confirm that the excellent safety profile of ADVATE remains unchanged after PEGylation.

Methods

Non-clinical safety studies with BAX 855 and its respective unbound polyethylene glycol (PEG) were conducted in several species. The distribution of a single dose of radiolabelled BAX 855 was further investigated in rats. Publically available safety data on PEG alone and PEGylated biomolecules were summarized and reviewed f

SUBMITTER: Stidl R 

PROVIDER: S-EPMC4737295 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature