Table 1.

Approved PEGylated FVIII and FIX products 2, 3, 10

Product	Generic name	Recombinant protein	PEG size	PEG conjugation	EU/US approvala	Approved age group for EU/USa	Approved for prophylaxis in EU/USa
BAY 94‐9027 (Jivi®)	damoctocog alfa pegol	BDD‐rFVIII	60 kDa branched	Maleimide linker to cysteine amino acid in A3 domain	Yes/Yes	≥12 y/≥12 y	Yes/Yes
N8‐GP (Esperoct®)	turoctocog alfa pegol	B‐domain truncated rFVIII	40 kDa (glycoPEGylation)	O‐linked glycan in truncated B‐domain	Yes/Yes	≥12 y/all ages	Yes/Yes
BAX 855 (Adynovate®/Adynovi®)	rurioctocog alfa pegol	rFVIII	20 kDa branched	Amino acids localised in B‐domain	Yes/Yes	≥12 y/all ages	Yes/Yes
N9‐GP (Refixia®/ REBINYN®)	nonacog beta pegol	rFIX	40 kDa branched (glycoPEGylation)	O‐linked glycan at Asn157 or Asn167	Yes/Yes	≥12 y/all ages	Yes/No

Abbreviations: Asn, asparagine; BDD, B‐domain deleted; rFIX, recombinant factor IX; rFVIII, recombinant factor VIII.

^aInformation obtained from https://www.ema.europa.eu/en and https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed October 2019.