Federal health officials say they approved a new injectable drug from Human Genome Sciences to treat inhalable anthrax.

HGS  is now part of GlaxoSmithKline (NYSE: GSK).

The Food and Drug Administration says raxibacumab will provide an alternative to antibiotic drugs that are currently the standard treatment for anthrax infection.

“Human Genome Science began work on raxibacumab in 2001 in response to the anthrax attacks in the United States. Our development program charted new territory in terms of the science and the regulatory pathway and was a result of our successful collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and FDA ”, said Sally Bolmer, senior vice president of Development and Regulatory Affairs at HGS.

Inhalation anthrax occurs when people breathe in the spores of Bacillus anthracis bacteria. The infection is treated with a 60-day course of antibiotics.

Raxibacumab is a manmade protein that blocks toxins produced by anthrax. It mimics naturally occurring antibodies in the human body that find and destroy harmful substances.

“Raxibacumab is an important part of an ongoing collaboration between GSK and the US government to address a range of public health concerns,” said Zhi Hong, senior vice president and head of Infectious Diseases, atGlaxoSmithKline. “It will be an important addition to the new approaches required to address our critical biodefense needs.”

The FDA approved the drug based on effectiveness studies in monkeys and rabbits that were infected with Anthrax. The drug’s safety was tested in 326 healthy human volunteers.

“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,” GSK noted in its announcement.

“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. 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.”

The FDA decision was announced Friday.

GSK operates its North American headquarters in RTP.

[GSK ARCHIVE: Check out 10 years of GSK stories as reported in WRAL Tech Wire.]