GlaxoSmithKline plc (GSK, GSK.L) announced Friday that the U.S. Food and Drug Administration 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 of inhalational anthrax when alternative therapies are not available or are not appropriate.
The company said that the effectiveness of raxibacumab is based solely on efficacy studies in animal models as it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. The safety of raxibacumab has been studied in healthy adult volunteers, however, there have been no studies of raxibacumab in the pediatric population.
Dosing in pediatric patients was derived using modelling based on data in adults.
The company noted that Raxibacumab does not have direct antibacterial activity. Raxibacumab does not cross into the brain and does not prevent or treat anthrax meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs.
Raxibacumab is the first monoclonal anti-toxin to be approved for inhalational anthrax. Anthrax is a rare and lethal disease, caused by a toxin producing bacterium. While antibiotics target the anthrax bacteria, raxibacumab offers an additional mechanism by blocking the activity of the anthrax toxin, which plays a key role in the progression of the disease. Raxibacumab demonstrated an improved survival rate over control in two relevant animal models both in combination with antibiotics and alone.
The company noted that the recommended adult dosage of raxibacumab is a single dose of 40 mg/kg given intravenously over a period of two hours and 15 minutes. Administer diphenhydramine within an hour of treatment to reduce the risk of infusion reactions.
Raxibacumab is not approved or licensed in Europe and currently is not approved in other parts of the world for the treatment or prophylaxis of patients with inhalational anthrax, the company said.
by RTT Staff Writer
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