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Label indication Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. FDA label
Raxibacumab · 1 trial · 1 indication
Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
| Arm | Type | Description |
|---|---|---|
| Raxibacumab arm | EXPERIMENTAL | A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose \>= 4 months following the first dose. |
| Name | Type | Description |
|---|---|---|
| Raxibacumab | BIOLOGICAL | Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5 |
Inclusion Criteria: * Enrolled and treated with raxibacumab in another HGS protocol, \>= 4 months ago. * Male or female \>= 18 and \<= 64 years of age. * Laboratory values that are Grade 0 by the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables. Subjects with laborat...
Raxibacumab is being developed for the therapeutic treatment of inhalation anthrax. It is an investigational monoclonal antibody studied in a Phase 2 clinical trial. It is not described as approved for any indication.
Raxibacumab is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor associated with the clinical development of this monoclonal antibody for inhalation anthrax.
Raxibacumab is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are listed. The program remains investigational and has not been described as approved.
Raxibacumab has been studied in one completed Phase 2 trial, NCT02016963. Titled an open-label, nonrandomized study to evaluate the safety and immunogenicity of Raxibacumab with reinjection, it enrolled 20 healthy adult volunteers aged 18 years and older.