2016
DOI: 10.1007/s40262-016-0492-2
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Abstract: BackgroundBAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A.ObjectiveThe aim of this study was to compare the pharmacokinetic (PK) profile of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM)Patients/MethodsIn this phase I, open-label, crossover study, men aged 18–65 years with severe hemophilia A and ≥150 exposure days to FVIII were randomized to receive a single intravenous infusion of 50 IU/kg BAY 81-897… Show more

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Cited by 32 publications
(73 citation statements)
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“…For BAY 81‐8937, the results from the LEOPOLD I study show that the 90% CIs for the AUC ratio compared with Kogenate FS in LEOPOLD I are almost completely within the bioequivalence window . These data were used in the regulatory authority reports and included a larger and more diverse study population (in terms of age range and race) than the phase 1 Bulgarian PK study, which suggested that the AUC of BAY 81‐8973 is increased compared with Advate (GMR (90% CI) 1.48 (1.41‐1.55) . The Bulgarian study was carried out in a single centre with patients all over the age of 18 years and all of White race.…”
Section: Resultsmentioning
confidence: 99%
“…For BAY 81‐8937, the results from the LEOPOLD I study show that the 90% CIs for the AUC ratio compared with Kogenate FS in LEOPOLD I are almost completely within the bioequivalence window . These data were used in the regulatory authority reports and included a larger and more diverse study population (in terms of age range and race) than the phase 1 Bulgarian PK study, which suggested that the AUC of BAY 81‐8973 is increased compared with Advate (GMR (90% CI) 1.48 (1.41‐1.55) . The Bulgarian study was carried out in a single centre with patients all over the age of 18 years and all of White race.…”
Section: Resultsmentioning
confidence: 99%
“…Furthermore, the expression of the gene for human heat shock protein 70 (HSP70), an intracellular chaperone, improves rFVIII expression and increases the purity of the product. 1,2 On the other hand, BAY 81-8973 reported an improved PK profile after a single dose of 50 IU/kg compared to another rFVIII (Advate ® ) in 18 adult patients in a randomized crossover PK study. 1 The PK study was performed after a single dose of 50 IU/kg and showed higher area under the curve (AUC), half-life (t 1/2 ) and mean residence time, as well as lower clearance in BAY 81-8973 group.…”
Section: Cross-sectional Comparative Study Of Pharmacokinetics and Efmentioning
confidence: 99%
“…1 The PK study was performed after a single dose of 50 IU/kg and showed higher area under the curve (AUC), half-life (t 1/2 ) and mean residence time, as well as lower clearance in BAY 81-8973 group. 2,3 The inter-individual variability in FVIII PK has been observed in all the FVIII products and justified the use PK-guided prophylaxis. No direct comparisons between the efficacies of rFVIII-FS and BAY 81-8973 were performed in these studies.…”
Section: Cross-sectional Comparative Study Of Pharmacokinetics and Efmentioning
confidence: 99%
“…Crossover PK studies have indicated a more favorable PK profile for BAY 81‐8973 than rFVIII‐FS or antihemophilic factor (recombinant) plasma/albumin‐free method (rAHF‐PFM; Advate®, Shire, Lexington, USA), supporting the potential for BAY 81‐8973 to provide a longer window of time above the FVIII trough level of 1% . This potential is supported by simulations comparing typical patients on BAY 81‐8973 or rAHF‐PFM …”
Section: Discussionmentioning
confidence: 91%
“…11,12 This potential is supported by simulations comparing typical patients on BAY 81-8973 or rAHF-PFM. 13 Measuring a patient's PK profile can be burdensome, due to the blood draws from patients with many clinic visits required; however, population PK modeling tools, such as WAPPS, provide a means for HTCs to transition factor concentrates in a rigorous and objective manner. They also provide patient-friendly information that help the patient to understand the implications of various prophylactic dosing strategies, to play an active part in making decisions about their treatment, and to adapt their treatment appropriately in the future.…”
Section: Discussionmentioning
confidence: 99%