Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anidulafungin · 4 trials · 3 indications
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral).
Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.EOT visit defined as last day of study treatment (IV or oral).
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species \[spp\]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.
| Arm | Type | Description |
|---|---|---|
| Anidulafungin IV | EXPERIMENTAL | All subjects meeting screening criteria will receive IV anidulafungin. |
| Treatment Group | EXPERIMENTAL | Option to treat with oral azole therapy following treatment with anidulafungin |
| Open | OTHER | This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia. |
| Name | Type | Description |
|---|---|---|
| Anidulafungin | DRUG | Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days. |
| Fluconazole | DRUG | Subjects may be switched to oral fluconazole \[6-12 mg/kg/day (not to exceed 800mg/day\] provided they meet specified criteria. Maximum total treatment duration is 49 days. |
| Voriconazole | DRUG | Oral Administration of Voriconazole |
Inclusion Criteria: * Subject must be either (1) at high risk for candidiasis (1 month - \< 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups) * Male and female patients from 1 month to less than 18 years of age. Exclusion Criteria: * Any pa...
Anidulafungin is an investigational small molecule being developed for infectious disease indications including neutropenia, invasive candidiasis, aspergillosis, candidiasis, and candidemia. It is administered intravenously and has been studied in clinical trials for the treatment of candidiasis and candidemia.
Anidulafungin is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule intended for the treatment of fungal infections such as candidiasis and candidemia.
Anidulafungin has completed Phase 3 clinical trials. It is an investigational drug and has not been reported as FDA approved. The completed trials include Phase 2 and Phase 3 studies for candidiasis and candidemia.
Anidulafungin has completed three clinical trials: NCT00037219, a Phase 2 study in 120 patients with candidiasis; NCT00041704, a Phase 2 study in 19 patients with azole-refractory mucosal candidiasis; and NCT00056368, a Phase 3 study in 256 patients with candidemia and invasive candidiasis. A fourth trial, NCT00537329, was a Phase 3 study in 43 Asian subjects with candidemia.
Anidulafungin is not reported to have any alternative names in the available data. The drug is referred to solely as Anidulafungin in the clinical trial information provided.