Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
rFVIII Product Shows Better PK Profile Than rFVIIIFc
Key clinical point: The recombinant factor VIII (rFVIII) product BAY 94‐9027 had a better pharmacokinetic (PK) profile than recombinant factor VIII-Fc fusion protein (rFVIIIFc) in patients with hemophilia A.
Major finding: Median time to achieve FVIII threshold levels (1 IU/dL) was 13 hours longer for BAY 94-9027 than it was for rFVIIIFc following a single intravenous dose of 60 IU/kg.
Study details: A pharmacokinetic crossover study of 18 patients with severe hemophilia A.
Disclosures: The study was funded by Bayer AG. The authors reported financial affiliations with Bayer, LFB, Octapharma, Pfizer, Roche, Shire, and several others.
Shah A et al. Ann Hematol. 2019 Jun 24. doi: 10.1007/s00277-019-03747-2.