Drugs / Raxibacumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed inhalational anthrax 1 milestone | |||||
| Filed | US (FDA) | — | inhalational anthrax | — | “In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax.” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | RAXIBACUMAB | — | 2018-01-11 | fda.gov ↗ |
| Approved | US (FDA) | RAXIBACUMAB | — | 2012-12-14 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02016963 | Jan → May 2008 | inhalational anthrax | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00639678 | Mar → Jul 2008 | — | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 41 trial · 1 met primary | ||||||
| Phase 4 | NCT02339155 | Feb 2015 → Jan 2017 | bacterial infectious disease | Emergent BioSolutions | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-12-12 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site emergentbiosolutions.com ↗
“We are pleased with the U.S. FDA approval of our sBLA for raxibacumab manufacturing at Emergent’s USMCA-compliant site in Winnipeg,” Joe Papa, president and CEO, Emergent. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-12 | Emergent BioSolutions | Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site emergentbiosolutions.com ↗ |
| 2017-10-03 | Emergent BioSolutions | Emergent BioSolutions Completes Acquisition of Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK emergentbiosolutions.com ↗ |
| 2017-07-19 | Emergent BioSolutions | Emergent BioSolutions to Acquire Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK emergentbiosolutions.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Raxibacumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02339155 ↗ |
| Known as | Abthrax | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108638 ↗ |
| Modality | Monoclonal antibody | “Raxibacumab is a human IgG1lambda monoclonal antibody directed against protective antigen, a component of the anthrax toxin.” PMID 19587338 ↗ Jul 2009 |
| Route | Intravenous | “Safety studies were conducted with intravenous raxibacumab (40 mg per kilogram) in 333 healthy human volunteers.” PMID 19587338 ↗ Jul 2009 |