Drugs / BioThrax
BioThrax
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | BioThrax | anthrax infection | 2010-07-14 | “the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule” emergentbiosolutions.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT03518125 | May 2018 → Jan 2019 | anthrax infection | Biomedical Advanced Research and Development Authority | Completed | No outcome recorded |
| Phase 2 | NCT01753115 | Dec 2012 → Aug 2013 | anthrax infection | Emergent BioSolutions | Completed | Met primary |
| Phase 2 | NCT00133484 | ? → May 2007 | anthrax infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01491607 | Nov 2011 → May 2012 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Phase 43 trials · 2 met primary | ||||||
| Phase 4 | NCT02339155 | Feb 2015 → Jan 2017 | bacterial infectious disease | Emergent BioSolutions | Completed | Met primary |
| Phase 4 | NCT01641991 | Jul 2012 → Mar 2013 | anthrax infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00119067 | May 2002 → Feb 2010 | — | Centers for Disease Control and Prevention | Completed | Met primary |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT04148118 Comparator | Jan 2020 → Sep 2021 | anthrax infection | BlueWillow Biologics | Completed | No outcome recorded |
| Phase 1 | NCT03352466 Comparator | Jan 2018 → May 2019 | — | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01263691 Comparator | Dec 2010 → May 2012 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Phase 2 | NCT01770743 Comparator | Jan 2013 → Feb 2014 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Phase 3 | NCT03877926 Comparator | Mar 2019 → Aug 2020 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2018-12-17 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives Health Canada Approval of BioThrax® (Anthrax Vaccine Adsorbed) emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) today announced that Health Canada has approved the company’s New Drug Submission (NDS) for its anthrax vaccine, BioThrax® (Anthrax Vaccine Adsorbed). |
| 2018-04-12 | Emergent BioSolutions | Regulatory Emergent BioSolutions Announces Successful Completion of Mutual Recognition Procedure for Market Authorisation of BioThrax in European Countries emergentbiosolutions.com ↗
Emergent BioSolutions Announces Successful Completion of Mutual Recognition Procedure for Market Authorization of BioThrax in European Countries |
| 2016-06-15 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives FDA Orphan Drug Status for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease emergentbiosolutions.com ↗ |
| 2015-11-24 | Emergent BioSolutions | Regulatory FDA Approves Emergent BioSolutions' BioThrax for Post-Exposure Prophylaxis emergentbiosolutions.com ↗ |
| 2015-10-12 | Altimmune, Inc. | Results Altimmune Chief Scientific Officer to Present at Two Premier Vaccine Conferences altimmune.com ↗
Vaccination with NasoShield produced serum anti-PA83 and toxin neutralizing antibody (TNA) titers with earlier onset and greater stability as compared BioThrax. |
| 2014-11-10 | Emergent BioSolutions | Regulatory Emergent BioSolutions Seeks Expanded BioThrax Label; Submits FDA Application for Post-Exposure Prophylaxis emergentbiosolutions.com ↗ |
| 2014-04-21 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease emergentbiosolutions.com ↗ |
| 2013-07-01 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany emergentbiosolutions.com ↗ |
| 2012-05-17 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives FDA Approval for BioThrax Administered Intramuscularly in a Three-Dose Primary Series Followed by Booster Doses emergentbiosolutions.com ↗ |
| 2011-08-26 | Emergent BioSolutions | Results Results of Emergent BioSolutions Phase 1a Study on Adjuvanted BioThrax Anthrax Vaccine Published in the Journal Vaccine emergentbiosolutions.com ↗
In the study, which enrolled 69 subjects, the addition of the CPG 7909 adjuvant to BioThrax(R) (Anthrax Vaccine Adsorbed), the only FDA-licensed anthrax vaccine, accelerated and enhanced the immune response to the vaccine in healthy volunteers. |
| 2011-06-23 | Emergent BioSolutions | Regulatory Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Singapore Health Sciences Authority (HSA) has approved Emergent's product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. |
| 2009-06-10 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its flagship product, BioThrax® (Anthrax Vaccine Adsorbed), has been granted a shelf life extension from 3 to 4 years by the U.S. Food and Drug Administration (FDA). |
| 2009-02-12 | Emergent BioSolutions | Regulatory Emergent BioSolutions Announces That BioThrax (Anthrax Vaccine Adsorbed) Receives Market Authorization in India emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax® (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection. |
| 2008-12-19 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Emergent's supplemental Biologics License Application (sBLA) for Anthrax Vaccine Adsorbed (BioThrax(R)), the only FDA-licensed vaccine to prevent disease caused by Bacillus anthracis. |
| 2008-10-09 | Emergent BioSolutions | Regulatory U.S. Government Issues Declaration Covering Emergent BioSolutions' BioThrax(R) and Anthrax Immune Globulin under Prep Act emergentbiosolutions.com ↗
In issuing this declaration, the Secretary of HHS determined that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency. |
| 2007-02-12 | Emergent BioSolutions | Regulatory FDA Grants Fast Track Designation to Emergent BioSolutions' BioThrax(R) for Post-Exposure Prophylaxis against Anthrax Infection emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax(R) (Anthrax Vaccine Adsorbed) as a post-exposure prophylaxis against anthrax infection. |
| 2006-01-10 | Emergent BioSolutions | Results New Studies Conclude BioThrax Plus Antibiotics Provide 100% Protection In Animals When Administered After Anthrax Exposure emergentbiosolutions.com ↗
Two separate government-sponsored studies demonstrated that BioThrax (Anthrax Vaccine Adsorbed), the world's only FDA-licensed anthrax vaccine produced by Emergent BioSolutions Inc., provided 100% protection against death in anthrax-infected animals treated with BioThrax combined with antibiotics. |
All press releases naming this drug 59 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BioThrax | “Protective antigen (PA)-specific antibody and cell-mediated immune (CMI) responses to annual and alternate booster schedules of Anthrax Vaccine Adsorbed (AVA; BioThrax) were...” PMID 26865594 ↗ Apr 2016 |
| Known as | Anthrax Vaccine Adsorbed | “BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.” NCT03877926 ↗3“Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine.” NCT00133484 ↗ “Anthrax Vaccine Adsorbed (AVA), for anthrax prophylaxis” PMID 32333847 ↗ Apr 2020 |
| Known as | AVA | “Protective antigen (PA)-specific antibody and cell-mediated immune (CMI) responses to annual and alternate booster schedules of Anthrax Vaccine Adsorbed (AVA; BioThrax) were...” PMID 26865594 ↗ Apr 20163“BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.” NCT03877926 ↗ “Anthrax vaccine absorbed made from Bacillus anthracis (AVA)” NCT00133484 ↗ |
| Known as | BioThraxTM | “Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine.” NCT00133484 ↗ |
| Modality | Vaccine | “Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI)” NCT00119067 ↗ |
| Route | Intramuscular | “BioThrax administered by the IM route” NCT00119067 ↗ |