anthrax immune globulin
Trade name: Anthrasil
Approved
Mar 24, 2015
Anthrax immune globulin, sold under the brand name Anthrasil, is a human immune globulin that is used in combination with antibiotics to treat anthrax. It was developed by Cangene and purchased in 2011 by the Biomedical Advanced Research and Development Authority (BARDA) under Project Bioshield. In March 2015, it was granted approval by the United States Food and Drug Administration for use in treating inhalation anthrax in conjunction with antibiotics. — Wikipedia
Clinical trial activity
2 trials · 6 clinical orgs · 1 marketing orgs
Earliest trial started Jul 1, 2007 (NCT00448253)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
- Jul 29, 2008
Orphan Drug Designation
2010s
- Mar 24, 2015
Earliest FDA Approval
- Mar 25, 2015
Emergent BioSolutions — First NDA Organization
- Mar 25, 2015
Emergent BioSolutions — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- Anthrax lethal factorANTAGONIST
lef antagonist
Approval history
- approvedMar 24, 2015
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaAnthrax immune globulin ↗
- NCATSVKZ83S945Z ↗
Also known as
- aigiv antibodies
- anthrasil
- anthrasil
- anthrax immune globulin
- anthrax immune globulin intravenous
- anthrax immune globulin intravenous (human)
- anthrivig
- np-015
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00845650 | Phase 1/Phase 2 (Phase 2) | Feb 1, 2009 | Emergent BioSolutions, National Institutes of Health (NIH), Shin Nippon Biomedical Laboratories |
| NCT00448253 | Phase 1 | Jul 1, 2007 | Cangene, Department of Health and Human Services, MDS Pharma |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cangene | For profit | 1 | 1 | 1 | 2007 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2007 |
| Emergent BioSolutions | For profit | 1 | 1 | 1 | 2009 |
| MDS Pharma | For profit | 1 | 0 | 1 | 2007 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2009 |
| Shin Nippon Biomedical Laboratories | For profit | 1 | 0 | 1 | 2009 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA | Mar 25, 2015 |