Title |
Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”
|
---|---|
Published in |
Frontiers in Microbiology, December 2015
|
DOI | 10.3389/fmicb.2015.01320 |
Pubmed ID | |
Authors |
Chia-Wei Tsai, Stephen Morris |
Abstract |
On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal antibody product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or "Animal Rule"). Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. The developmental process required for approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues. |
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Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 50% |
Scientists | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 1% |
Kenya | 1 | 1% |
Unknown | 72 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 15 | 20% |
Student > Ph. D. Student | 12 | 16% |
Researcher | 9 | 12% |
Student > Master | 8 | 11% |
Other | 3 | 4% |
Other | 7 | 9% |
Unknown | 20 | 27% |
Readers by discipline | Count | As % |
---|---|---|
Biochemistry, Genetics and Molecular Biology | 16 | 22% |
Immunology and Microbiology | 8 | 11% |
Agricultural and Biological Sciences | 7 | 9% |
Pharmacology, Toxicology and Pharmaceutical Science | 6 | 8% |
Medicine and Dentistry | 5 | 7% |
Other | 10 | 14% |
Unknown | 22 | 30% |