The Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) voted 16 to 1 in support of the clinical benefit of GlaxoSmithKline's raxibacumab for the treatment of inhalational anthrax, with one abstention. In addition, the committee voted 18 – 0 in favour of the risk-benefit profile of raxibacumab.
Anthrax is a lethal disease that is seen only under rare circumstances, and for this reason, the raxibacumab anti-toxin development programme was designed to meet the criteria for approval under the regulatory pathway using animal data when human studies are not ethical or feasible.
“Anthrax has been identified by the US Government as a serious potential threat and there is a need for new treatment options in the event of an anthrax attack in the US. The development of raxibacumab reflects a collaboration of industry and government in response to this public health need, and we are pleased with the outcome of the meeting which represents years of dedication to this project by Human Genome Sciences”, said Zhi Hong, senior vice president & head of infectious diseases, GlaxoSmithKline.
The Committee provides non-binding recommendations for consideration by FDA, with the final decision on approval made by FDA. The Prescription Drug User Fee Act (PDUFA) goal date for raxibacumab is 15th December 2012. Raxibacumab is an investigational medicine and is not approved or licensed anywhere in the world.
Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis and is being developed for the treatment of inhalational anthrax.
The most commonly observed adverse events were headaches, upper respiratory tract infection, nausea, pain in extremity (pain in limbs) and pruritus (skin itching). Local skin reaction in one study has led to the recommendation that an anti-histamine be administered prior to infusion.
Raxibacumab was 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), US 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.