Approval Probability
TA Base Rate
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Label indication VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis ( 1.1 ) • Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) • Esophageal candidiasis ( 1.3 ) • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or… FDA label
Also known as voriconazole (Vfend), Vfend
voriconazole · 7 trials · 7 indications
Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion \[fever, body temperature \<36 or \>38 degrees Celsius, graft-versus-host disease, use of corticosteroids\]; and 1 microbiological criterion \[fungal or yeasts\]; or clinical criteria \[abnormal site consistent with infection\]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.
AUC12,ss was obtained by the Linear/Log trapezoidal method.
AUC12,ss was obtained by the Linear/Log trapezoidal method.
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
| Arm | Type | Description |
|---|---|---|
| Voriconazole | ACTIVE_COMPARATOR | Voriconazole monotherapy |
| Voriconazole and Anidulafungin | EXPERIMENTAL | Combination therapy with voriconazole and anidulafungin |
| Early treatment | EXPERIMENTAL | Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (\< 38.0 °C) for 7 days with neutrophil counts \< 500/µL, or if the patient is afebrile (\< 38.0 °C) for 2 days with neutrophil counts \> 500/µL. |
| Deferred treatment | OTHER | Treatment with voriconazole (for dosage see "early treatment arm") is initiated only if a patient is persistently febrile on day 5 after the onset of fever despite antibiotic treatment. |
| 1.0 | EXPERIMENTAL | Immunocompromised children aged 2 to \<15 and 12 to \<15 years weighing \<50 kg who are at high risk for systemic fungal infection. |
| 2.0 | EXPERIMENTAL | Immunocompromised children aged 12 to \<15 years weighing more than 50 kg who are at high risk for systemic fungal infection. |
| Children aged 2 to <12 years | EXPERIMENTAL | Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| voriconazole | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| anidulafungin | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| voriconazole (Vfend) | DRUG | voriconazole, early treatment |
Inclusion Criteria: * Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy; * Diagnosis of possible, probable, or proven invasive aspergillosis. Exclusion Criteria: * Patients with aspergilloma or chronic aspergillosis * Receipt ...
Voriconazole is an antifungal medicine used to treat serious fungal infections, including aspergillosis, aspergilloma, and candidiasis. It is also studied in patients with neutropenia who are at risk for systemic fungal infection. It belongs to the infectious disease therapeutic area and is given for invasive fungal disease.
Voriconazole is developed and marketed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company behind the brand-name version of the drug.
Voriconazole has completed Phase 3 clinical development. Its registrational-stage trial, NCT00531479, was a Phase 3 study of anidulafungin plus voriconazole versus voriconazole for invasive aspergillosis. The drug is an established small-molecule antifungal, and no active trials are currently listed.
Voriconazole has been studied in completed trials including NCT00531479, a Phase 3 trial in invasive aspergillosis with 459 patients, and two Phase 2 pediatric pharmacokinetic and safety studies, NCT01383993 in Japan and NCT00739934 in the United States. A Phase 1 pediatric study, NCT00174473, enrolled 49 children with neutropenia.
Yes, voriconazole is also known by the brand name Vfend. Vfend is the trade name for voriconazole, the same active antifungal ingredient developed by Pfizer.