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Efficacy & Safety
PK & Time to Threshold

In a head-to-head study, Kovaltry demonstrated a superior PK profile compared to rAHF-PFM1

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FVIII level decay curve for Kovaltry vs rAHF-PFM: single 50 IU/kg infusion in chromogenic assay1

graph
  • A crossover study showed that when these two products are used in an intrapatient evaluation, significant differences are observed1*
  • Each patient was randomized to a single dose of Kovaltry or rAHF-PFM – then switched to the other treatment
  • At several timepoints, Kovaltry has shown a better PK profile than rAHF-PFM

*p<0.0001.1

<†Results were also confirmed in a one-stage assay.1

‡Data are geometric means.1

rAHF-PFM, antihemophilic factor (recombinant) plasma/albumin-free method

Give your patients more time doing what they need to do... with Kovaltry

Kovaltry vs rAHF-PFM: time to threshold1

threshold
  • All data were derived from a simulation of 1000 virtual patients in a popPK model, which provided an accurate description of chromogenic assay data (n=18).
  • A similar trend in median time to threshold was observed for 25, 30 and 40 IU/kg doses.1

Adapted from Shah et al. 2017

*Example patient only for illustrative purposes. PopPK, population PK; rAHF-PFM, antihemophilic factor (recombinant) plasma/albumin-free method.

References

  • Shah A, Solms A, Garmann D. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017;56(9):1045-1055. Return to content