The Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) has supported the clinical benefit of GlaxoSmithKline's raxibacumab to treat inhalational anthrax.
In addition, the committee also favoured the risk-benefit profile of raxibacumab.
The raxibacumab anti-toxin development programme has been designed to get approval under the regulatory pathway using animal data when human studies are not ethical or feasible.
GlaxoSmithKline senior vice president and head of infectious diseases Zhi Hong said 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 today's meeting which represents years of dedication to this project by Human Genome Sciences," Hong added.
The Committee has also suggested FDA to consider non-binding recommendations for consideration along with FDA's e final decision on approval.
The Prescription Drug User Fee Act (PDUFA) goal date for raxibacumab is 15 December 2012.
Raxibacumab is an investigational monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis, which is not approved or licensed in the world.
