- |||||||||| Nplate (romiplostim) / Amgen, Kyowa Kirin, Abthrax (raxibacumab) / Emergent Biosolutions
Review, Journal: United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism. (Pubmed Central) - Aug 18, 2023
For bioterrorism-associated anthrax, the FDA approved five antibiotics (doxycycline, penicillin-G, levofloxacin, moxifloxacin, and ciprofloxacin), two monoclonal antibodies (obiltoxaximab and raxibacumab), one polyclonal antitoxin (Anthrax Immune Globulin Intravenous) and two vaccines (Anthrax Vaccine Adsorbed and Anthrax Vaccine Adsorbed with an adjuvant)...Two potential mass public health disasters are aerosolized anthrax dissemination and radiological incidents. Five agents authorized for anthrax emergencies only have FDA approval for this indication, five antibiotics have FDA approvals as antibiotics for common infections and for bacillus anthrax, and four agents have regulatory approvals for supportive care for cancer and for radiological incidents.
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions, Anthrasil (AIGIV) / Emergent Biosolutions
Journal: Pre- and Postlicensure Animal Efficacy Studies Comparing Anthrax Antitoxins. (Pubmed Central) - Nov 15, 2022
Five agents authorized for anthrax emergencies only have FDA approval for this indication, five antibiotics have FDA approvals as antibiotics for common infections and for bacillus anthrax, and four agents have regulatory approvals for supportive care for cancer and for radiological incidents. These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment.
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions, Anthrasil (AIGIV) / Emergent Biosolutions
Journal: Pre- and Postlicensure Animal Efficacy Studies Comparing Anthrax Antitoxins. (Pubmed Central) - Oct 25, 2022
These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment. These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment.
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions, Zinplava (bezlotoxumab) / Merck (MSD)
Journal: Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives. (Pubmed Central) - Mar 26, 2022
We also highlight the recent developments in pre-clinical research sector to develop exotoxin-targeted drug modalities, i.e., monoclonal antibodies, antibody fragments, antibody mimetics, receptor analogs, neutralizing scaffolds, dominant-negative mutants, and small molecules. We describe how these exotoxin-targeted drug modalities work with high-resolution structural knowledge and highlight their advantages and disadvantages as antibiotic alternatives.
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions
Clinical, PK/PD data, Journal: Population pharmacokinetics of raxibacumab in healthy adult subjects. (Pubmed Central) - Mar 11, 2022
A dose of 40 mg/kg provided comparable exposure across the overall healthy subject population. IIV in raxibacumab versus time profiles could partially be accounted for by differences in body weight.
- |||||||||| Synagis (palivizumab) / AbbVie, AstraZeneca, SOBI
Review, Journal: Monoclonal Antibodies for Protozoan Infections: A Future Reality or a Utopic Idea? (Pubmed Central) - Oct 31, 2021
Nonetheless, only four mAbs are currently employed for infectious diseases: Palivizumab, for the prevention of respiratory syncytial virus (RSV) infections, Raxibacumab and Obiltoxaximab, for the prophylaxis and treatment against anthrax toxin and Bezlotoxumab, for the prevention of Clostridium difficile recurrence...In this review, we present the efforts that are being made in the evaluation of mAbs for the prevention or treatment of leishmaniasis, Chagas disease, malaria, and toxoplasmosis. Particular emphasis will be placed on the potential strengths and weaknesses of biological treatments in the control of these protozoan diseases that are still affecting hundreds of thousands of people worldwide.
- |||||||||| Synagis (palivizumab) / AbbVie, AstraZeneca, SOBI
Journal: Monoclonal antibodies against infectious microbes: so long and too little! (Pubmed Central) - Sep 23, 2021
Among the three antibacterial mAbs, raxibacumab (ABthrax®/ Anthrin®) and obiltoxaximab (Anthim®) are indicated for the treatment and prophylaxis of inhalation anthrax due to Bacillus anthracis; bezlotoxumab (Zinplava®) is used to reduce the recurrence of Clostridium difficile infection...The current cutting-edge engineering technologies revolutionizing the production of mAbs include phage-displayed antibody libraries, cloning from single-memory B cells or single-antibody-secreting plasma B cells, proteomics-directed cloning of mAbs from serum clubbed with high-throughput sequencing techniques. Yet, the cost of manufacture continues to be the main limiting factor.
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions
Trial completion date, Trial primary completion date: Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis (clinicaltrials.gov) - Sep 27, 2018
P4, N=100, Not yet recruiting,
This finding suggests that combining raxibacumab with AVA might provide added benefit in postexposure prophylaxis against inhalational anthrax. Trial completion date: Apr 2021 --> Jul 2025 | Trial primary completion date: Apr 2021 --> Jul 2025
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions
Trial initiation date, Trial primary completion date: Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis (clinicaltrials.gov) - Nov 27, 2017
P4, N=100, Not yet recruiting,
Trial completion date: Apr 2021 --> Jul 2025 | Trial primary completion date: Apr 2021 --> Jul 2025 Initiation date: Sep 2017 --> Sep 2018 | Trial primary completion date: Apr 2020 --> Apr 2021
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions
Enrollment open, Trial primary completion date: Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed (clinicaltrials.gov) - Feb 10, 2016
P4, N=30, Recruiting,
Initiation date: Sep 2016 --> Sep 2017 | Trial primary completion date: Mar 2018 --> Apr 2020 Active, not recruiting --> Recruiting | Trial primary completion date: Jul 2015 --> Jan 2017
- |||||||||| Abthrax (raxibacumab) / Emergent Biosolutions
Enrollment closed: Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed (clinicaltrials.gov) - May 26, 2015
P4, N=30, Active, not recruiting,
Active, not recruiting --> Recruiting | Trial primary completion date: Jul 2015 --> Jan 2017 Recruiting --> Active, not recruiting
|
