FDA Approves First Anthrax Antitoxin - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Approves First Anthrax Antitoxin


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Dec. 14, 2012, FDA approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab is a monoclonal antibody that neutralizes toxins produced by B. anthracis.

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). HGS was acquired by GlaxoSmithKline in July, 2012, making raxibacumab part of GSK’s portfolio.

Raxibacumab is the first monoclonal antibody approved under FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. In this case, because inhalational anthrax is a rare and lethal disease, it is not possible to conduct adequate efficacy trials in humans. 

In addition, the drug is the first to be developed under Project Bioshield to receive FDA approval, according to a press release from HHS.  The Project Bioshield Act was signed in 2004 and provides funding to support and expedite the development and procurement of medical countermeasures against chemical, biological, radiological, and nuclear threats. According to GSK’s press release, the US Government is currently the sole recipient of raxibacumab supplies.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here