Baxter hemophilia drug successful in Phase 3 trial


In a 138-patient Phase 3 clinical trial evaluating the safety and efficacy of Baxter International's (BAX +0.9%) BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A, the product candidate met its primary endpoint of reducing annualized bleed rates (ABR) in the prophylaxis arm versus the on-demand arm.

Patients in the twice-weekly prophylaxis arm experienced a 95% reduction in median ABR compared to the on-demand group (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes considering that 96% were controlled with one or two infusions.

The half life of BAX 855 was 1.4x - 1.5x that of Advate [antihemophilic factor (recombinant)].

The company expects to submit its BLA for BAX 855 before the end of 2014.

From other sites
Comments (1)
  • Captain Pike
    , contributor
    Comments (890) | Send Message
     
    cool
    21 Aug 2014, 10:10 AM Reply Like
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs