FDA Panel Seeks ABthrax Data

A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs. 

The panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment. 

Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit of ABthrax. Furthermore, the drug appeared to be effective when used with antibiotics in rabbits and monkeys. The same panel also voted in favor of using data from the animal studies to predict how the drug will work in humans. However, more data is required for the purpose. Last week, the FDA expressed concerns regarding some of the data submitted in the company's application. 

As a reminder, Human Genome had filed a Biologics License Application with the FDA in May 2009. The company is slated to receive an additional $10 million from the U.S. Government on FDA approval. 

ABthrax, which received Fast Track Product and Orphan Drug designations for anthrax, is being developed under a contract entered into in 2006 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). 

Human Genome is under contract to deliver doses of ABthrax to the U.S. Strategic National Stockpile, which stores huge quantities of medicine and medical supplies to be used in national emergencies such as a flu outbreak, terrorist attacks or earthquakes that are brutal enough to deplete local supplies. The company delivered 20,000 doses of the drug to the U.S. Strategic National Stockpile in the first quarter of 2009. In Jul 2009, Human Genome secured a new purchase order for 45,000 doses of ABthrax to be delivered to the U.S. Strategic National Stockpile over a three-year period. 

Currently, we are Neutral on Human Genome.

Read the full analyst report on HGSI