GSK receives FDA approval for raxibacumab anti-toxin for the treatment of
LONDON, Dec. 14, 2012
LONDON, Dec. 14, 2012 /PRNewswire/ --GlaxoSmithKline plc [LSE/NYSE: GSK]
announced today that the U.S. Food and Drug Administration (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 of inhalational anthrax when
alternative therapies are not available or are not appropriate.
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. 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 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 andHead of Infectious Diseases, GlaxoSmithKline.
"It will be an important addition to the new approaches required to address
our critical biodefense needs."
"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, where the drug was
discovered and developed. HGS was recently acquired by GSK.
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 safety of raxibacumab has been evaluated in 326 healthy adult volunteers
treated with the recommended dose. Infusion reactions were reported in
clinical trials including reports of rash, urticaria (hives) and pruritus
(itching). If these reactions occur, slow or interrupt raxibacumab infusion
and administer appropriate treatment based on the severity of the reaction.
Patients should be premedicated with diphenhydramine (an antihistamine) before
treatment. The most frequently reported adverse reactions(less than or equal
to1.5%) were rash, pain in an extremity (arms and legs), pruritus (itching)
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. The recommended dose for children is based on weight.
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.For Full US Prescribing Information,
please visit, http://www.gsk.com/products/index.htm
Raxibacumab was discovered and developed by Human Genome Sciences (HGS) in
conjunction with the Biomedical Advanced Research and Development Authority
(BARDA) of the Office of the Assistant Secretary for Preparedness and Response
(ASPR), U.S. Department of Health and Human Services (HHS) under contract
number HHS010020050006C. It is now part of GSK's portfolio, following GSK's
acquisition of HGS in July 2012. The development of raxibacumab is the result
of a coordinated response to a recognised public health threat and the US
government's request for new medical countermeasures in the event of an
anthrax attack against the civilian population. The US Government is currently
the sole recipient of raxibacumab supplies.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and
healthcare companies – is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further
information please visit www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk factors' in the 'Financial review & risk' section in the
company's Annual Report 2011 included as exhibit 15.2 to the company's Annual
Report on Form 20-F for 2011.
SOURCE GlaxoSmithKline plc
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