Drugs / AVP-21D9
last change Apr 2014 re-read 3 minutes ago

AVP-21D9

also known as Thravixa

Monoclonal antibody

Investigated by
Emergent BioSolutions · National Institutes of Health (NIH)

Trials 1

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT01202695 Aug 2010 → Jun 2011 anthrax infection Emergent BioSolutions Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2010-11-04 Emergent BioSolutions Regulatory Emergent BioSolutions Receives Orphan Drug Designation for Its Investigational Monoclonal Antibody for the Treatment of Inhalation Anthrax emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its fully human anthrax monoclonal antibody AVP-21D9, which is in development for the treatment of inhalation anthrax, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).
2010-10-01 Emergent BioSolutions Regulatory Emergent BioSolutions Receives Fast Track Designation for Its Investigational Monoclonal Antibody for the Treatment of Inhalational Anthrax emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as AVP-21D9 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01202695 ↗
Known as Thravixa “An anthrax antitoxin, AVP-21D9, also known as Thravixa (fully human anthrax monoclonal antibody), is being developed as a therapeutic agent against anthrax toxemia.” PMID 24733473 ↗ Apr 2014
Modality Monoclonal antibody “fully human anthrax monoclonal antibody” PMID 24733473 ↗ Apr 2014
Route Intravenous “intravenously, single dose” NCT01202695 ↗