Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study

Skoura, Nancy; Wang‐Jairaj, Jie; Pasqua, Oscar Della; Chandrasekaran, Vijayalakshmi; Billiard, Julia; Yeakey, Anne; Smith, William B.; Steel, Howard H.; Tan, Lionel

doi:10.1016/s1473-3099(20)30069-4

Cited by 16 publications

(15 citation statements)

References 24 publications

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“…A separate analysis has also shown that coadministration of raxibacumab with subcutaneous administration of Anthrax Vaccine Adsorbed, as part of a post-exposure prophylaxis regimen in healthy subjects, did not affect the disposition of raxibacumab [20]. In addition, PK parameter estimates were of the same order of magnitude of obiltoxaximab, which is another mAb against AT [21].…”

Section: Discussionmentioning

confidence: 90%

Population pharmacokinetics of raxibacumab in healthy adult subjects

Oosterholt

Pasqua

2021

Brit J Clinical Pharma

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What is already known about this subject o Raxibacumab is indicated for the treatment of adult and paediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs. It is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. What this study addso Here we have characterised the effect of baseline demographic characteristics on the disposition of raxibacumab and their implications for the dose rationale.o The population pharmacokinetic model provides the basis for further evaluation of the dose rationale in a paediatric population in a future post-marketing study.

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Section: Discussionmentioning

confidence: 90%

Population pharmacokinetics of raxibacumab in healthy adult subjects

Oosterholt

Pasqua

2021

Brit J Clinical Pharma

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“…A post-approval trial of 573 was performed to assess the efficacy and safety of AVA after raxibacumab treatment. AVA and raxibacumab co-administration does not decrease AVA immunogenicity, and no AEs were reported ( Skoura et al, 2020 ) [MC].…”

Section: Bacterial Vaccinesmentioning

confidence: 99%

Vaccines

Ambler

Towne

Brooks

2021

Side Effects of Drugs Annual

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“…There are two main types of treatments, namely antibodies and chemical inhibitors. A nice example of toxin-directed antibodies is raxibacumab (GlaxoSmithKline), an already approved monoclonal antibody used to treat inhalational anthrax, a form of this infectious disease caused by breathing in the spores of the bacterium B. anthracis [52]. Another example is the FDA-and EMA-approved human monoclonal antibody Bezlotoxumab (Merck), which blocks C. difficile toxin B and prevents recurrent infections by this pathogen [53].…”

Section: Antivirulence Treatmentsmentioning

confidence: 99%

Developing Diagnostic and Therapeutic Approaches to Bacterial Infections for a New Era: Implications of Globalization

et al. 2020

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In just a few months, the current coronavirus pandemic has exposed the need for a more global approach to human health. Indeed, the quick spread of infectious diseases and their unpredictable consequences, in terms of human lives and economic losses, will require a change in our strategy, both at the clinical and the research level. Ultimately, we should be ready to fight against infectious diseases affecting a huge number of people in different parts of the world. This new scenario will require rapid, inexpensive diagnostic systems, applicable anywhere in the world and, preferably, without the need for specialized personnel. Also, treatments for these diseases must be versatile, easily scalable, cheap, and easy to apply. All this will only be possible with joint support of the governments, which will have to make the requirements for the approval of new therapies more flexible. Meanwhile, the pharmaceutical sector must commit to prioritizing products of global interest over the most profitable ones. Extreme circumstances demand a vehement response, and any profit losses may well pay dividends going forward. Here, we summarize the developing technologies destined to face the current and future health challenges derived from infectious diseases and discuss which ones have more possibilities of being implemented.

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Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study

Cited by 16 publications

References 24 publications

Population pharmacokinetics of raxibacumab in healthy adult subjects

Population pharmacokinetics of raxibacumab in healthy adult subjects

Vaccines

Developing Diagnostic and Therapeutic Approaches to Bacterial Infections for a New Era: Implications of Globalization

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