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Anidulafungin

Phase 3

Candidemia | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 4, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials2
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00761267Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive CandidiasisPHASE3 COMPLETED 70Feb 1, 2009Feb 1, 2018Apr 4, 201945 United States, Brazil +8
NCT00537329Anidulafungin In Treatment Of Candidemia In Asian SubjectsPHASE3 COMPLETED 43Jan 1, 2008Mar 1, 2009Mar 9, 201013 India, Philippines +2
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 6 weeks after EOT (up to 91 days)

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).

Number of Participants With Laboratory Abnormalities
Baseline up to 6 weeks after EOT (up to 91 days)

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).

Number of Subjects With Global Response of Success at End of Treatment
End of treatment (EOT) = Day 5 up to Day 42

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.

Secondary Endpoints
Number of Participants With Global Response
End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup
Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion
Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup
Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Anidulafungin IVEXPERIMENTALAll subjects meeting screening criteria will receive IV anidulafungin.
OpenOTHERThis is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.
Interventions
NameTypeDescription
AnidulafunginDRUGDay 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.
FluconazoleDRUGSubjects 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.
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Eligibility Criteria
Age Range1 Month — 17 Years
SexALL
Healthy VolunteersNo
Study Sites45

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...

Countries:United StatesBrazilCanadaGreeceItalyRussiaSouth KoreaSpainTaiwanUnited KingdomIndiaPhilippinesThailand
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