Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Eraxis
Anidulafungin · 8 trials · 5 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 |
| Anidulafungin, VER002 | DRUG | - |
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 antifungal medicine studied for treating fungal infections including candidemia, invasive candidiasis, and aspergillosis, and it has also been evaluated in patients with neutropenia. Its clinical program has focused on candidemia and invasive candidiasis in adults and children, including patients in intensive care settings.
Anidulafungin is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company associated with the clinical development program for this antifungal agent.
Anidulafungin is in Phase 2 development. It is an investigational small molecule antifungal, and the clinical program includes completed Phase 1 and Phase 3 studies in conditions such as candidemia, invasive candidiasis, and neutropenia.
Anidulafungin has been studied in completed trials including NCT00761267, a Phase 3 study of pharmacokinetics, safety, and efficacy in children with invasive candidiasis; NCT00689338, a Phase 3 candidemia and invasive candidiasis intensive care study; NCT00537329, a Phase 3 candidemia study in Asian subjects; and NCT00056381, a Phase 1 study in immunocompromised children with neutropenia.
Yes, anidulafungin is also known as VER002. Both names refer to the same antifungal small molecule developed by Pfizer, so searches for either name point to the same drug and clinical program.