Table II.

VWF/FVIII concentrates licensed in Italy for the treatment of von Willebrand disease and tested in clinical studies based upon efficacy and PK

Product	Manufacturer	Fractionation method (ratio)	Viral inactivation	VWF:RCo/Ag	VWF:RCo/FVIII
Alphanate	Alpha Therapeutics	Heparin ligand chromatography	S/D + dry heat, (80°C, 72h)	0.47 ±0.1*	0.91 ±0.2*
Fanhdi	Grifols	As above	S/D + dry heat (as above)	0.47 ±0.1*	1.04 ±0.1*
Haemate P	CSL Behring	Multiple precipitation	Pasteurization (60°C, 10 hr)	0.59 ±0.1*	2.45 ±0.3*

Abbreviations: VWF, von Willebrand factor; RCo, ristocetin cofactor; Ag, antigen; FVIII, factor VIII; S/D, solvent/detergent (TNBP/polysorbate 80); D detergent.

^*Means ± SD are derived from the analysis of 10 lots for each VWF/FVIII product. The analysis was independently done using in house methods at the Milan Hemophilia Center, not with the methods recommended to manufacturers by the European Pharmacopea.

Another VWF/FVIII product (Immunate) is licensed in Italy for VWD management. The characteristics of this product can be derived only from the information provided by the manufacturer³, because this product was not made available for our independent analysis