Anthrax Antibody Resubmitted to US FDA by HGS
A week prior to the closing date Human Genome Sciences (HGS) have fixed for prospective buyers to submit bids, HGS have announced that US regulators are to review raxibacumab again for the treatment’s previously-rejected anthrax medication.
The US Food and Drug Administration (FDA) have confirmed the receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab and set a Prescription Drug User Fee Act (PDUFA) action date of December 15th for it. The agency has considered the re-filing a complete response to the letter they sent out in November 2009, which invited further analyses of existing data along with additional information.
Human Genome Sciences have noted that the Biologics License Application resubmission encloses a further evaluation of histopathology of survivors and non-survivors in animal studies, evaluation of potential added benefit of using the drug alongside antibiotics as opposed to just taking antibiotics “and additional validation to confirm previous data.”
Raxibacumab is a human monoclonal antibody “that represents a novel way to address the anthrax threat,” the organisation commented, adding that while antibiotics are able to kill the anthrax bacteria, “they are not effective against the deadly toxins that the bacteria produce.”
The medication is being developed under a agreement signed in 2006 with the US government, and in 2009 Human Genome Sciences supplied the initial 20,000 doses of raxibacumab to the US national stockpile, and the government implemented their option to purchase 45,000 further doses for emergency use in treating inhalation anthrax.
Meanwhile, reports have been circulating that Celgene could be planning a proposal for Human Genome Sciences as the HGS’s deadline for bids draws nearer (July 16th 2012). However, most spectators believe that the lone bid will be GlaxoSmithKline’s $2.60 billion which has been repeatedly turned down by the HGS board.