Lonoctocog alfa (rVIII-SingleChain; Afstyla) is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study of the AFFINITY programme in children <12 years of age and in adults with severe haemophilia A. Recombinant FVIII-SingleChain molecule (lonoctocog alpha) had a higher affinity for von Willebrand factor than full-length recombinant FVIII and displayed other favourable pharmacokinetic/pharmacodynamic properties in non-clinical models, too.