Bayer's Jivi 'beats' Sanofi's Eloctate in hemophilia A study

Results from a head-to-head Phase 1 study evaluating the pharmacokinetic (PK) profiles of Bayer's (OTCPK:BAYRY) Jivi (antihemophilic factor [recombinant] PEGylated-aucl) compared to Sanofi's (NASDAQ:SNY) Eloctate (recombinant FVIII fusion protein) in adults with severe hemophilia A who previously received any factor VIII product showed Jivi's non-inferiority (no worse than) to Eloctate in terms of area under the curve (AUC), the primary PK endpoint. AUC is a plot of drug concentration in blood plasma over time. In other words, it is a measure of the amount of drug available to deliver the therapeutic effect.

According to Bayer, if one outlier participant is excluded (the patient had pre-existing anti-PEG antibodies and had significantly reduced AUC with JIVI), then JIVI showed a 25% higher mean AUC, 20% slower clearance and 7% longer terminal half-life versus Eloctate.

https://seekingalpha.com/news/3491080-bayers-jivi-beats-sanofis-eloctate-hemophilia-study