GlaxoSmithKline announced that the FDA has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis when alternative therapies are not available or are not appropriate.
The safety of raxibacumab has been studied in 326 healthy adult volunteers, but no studies have been conducted in the pediatric population. Dosing in pediatric patients was derived using data from adult models. Raxibacumab demonstrated an improved survival rate over the control in two relevant animal models both in combination with antibiotics and alone. The effectiveness of raxibacumab is based solely on efficacy studies in animal models.
Raxibacumab is a human monoclonal antibody that represents a novel way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by bacteria into blood and tissues.
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