Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule
On December 14, 2012, the FDA approved raxibacumab, the first 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 pa...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2015-12-01
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| Series: | Frontiers in Microbiology |
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| Online Access: | http://journal.frontiersin.org/Journal/10.3389/fmicb.2015.01320/full |
| _version_ | 1818020284003778560 |
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| author | Chia-Wei eTsai Stephen eMorris |
| author_facet | Chia-Wei eTsai Stephen eMorris |
| author_sort | Chia-Wei eTsai |
| collection | DOAJ |
| description | On December 14, 2012, the FDA approved raxibacumab, the first 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 are not appropriate. The 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. |
| first_indexed | 2024-04-14T08:02:59Z |
| format | Article |
| id | doaj.art-121500694f82426ca8f2440e2083cba8 |
| institution | Directory Open Access Journal |
| issn | 1664-302X |
| language | English |
| last_indexed | 2024-04-14T08:02:59Z |
| publishDate | 2015-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Microbiology |
| spelling | doaj.art-121500694f82426ca8f2440e2083cba82022-12-22T02:04:50ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2015-12-01610.3389/fmicb.2015.01320156956Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal ruleChia-Wei eTsai0Stephen eMorris1Department of Health and Human ServiceBioProtection Systems/NewLink Genetics CorpOn December 14, 2012, the FDA approved raxibacumab, the first 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 are not appropriate. The 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.http://journal.frontiersin.org/Journal/10.3389/fmicb.2015.01320/fullAnthropometryAnimal ruleRaxibacumabFDA licencureanthrax therapeutics |
| spellingShingle | Chia-Wei eTsai Stephen eMorris Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule Frontiers in Microbiology Anthropometry Animal rule Raxibacumab FDA licencure anthrax therapeutics |
| title | Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule |
| title_full | Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule |
| title_fullStr | Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule |
| title_full_unstemmed | Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule |
| title_short | Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule |
| title_sort | approval of raxibacumab for the treatment of inhalation anthrax under the us food and drug administration animal rule |
| topic | Anthropometry Animal rule Raxibacumab FDA licencure anthrax therapeutics |
| url | http://journal.frontiersin.org/Journal/10.3389/fmicb.2015.01320/full |
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