GlaxoSmithKline plc (GSK) said Friday that the U.S. Food and Drug Administration has approved Raxibacumab as the first monoclonal anti-toxin for the treatment of inhalational anthrax due to Bacillus anthracis bacteria.
The FDA nod was expected as a panel last month recommended approval of Raxibacumab, an injectable medicine, on the basis of a favorable risk-benefit profile.
The approval means Raxibacumab can be used to treat adults and pediatric patients with inhalational anthrax in combination with antibacterial drugs and for prophylaxis of inhalational anthrax in the absence/ineffectiveness of alternative therapies.
Raxibacumab was developed by Human Genome Sciences, which Glaxo acquired in July this year. The effectiveness of the drug is based on studies involving rabbits and monkeys, given that it is not ethical or feasible to conduct trials with humans exposed to anthrax. Raxibacumab showed an improved survival rate both in combination with antibiotics and alone.
The drug's safety has also been studied in 326 healthy adult volunteers.
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.
The most frequent adverse reactions for Raxibacumab were rash, pain in an extremity (arms and legs), itching and somnolence.
Glaxo closed Friday at $44.12, up 0.41%, on a volume of 4 million shares on the NYSE. In London, the stock closed at 1,364 pence, down 0.11%, on a volume of 7 million shares.
by RTT Staff Writer
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