Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 Vfend
Vfend- voriconazole · 1 trial · 1 indication
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
| Arm | Type | Description |
|---|---|---|
| Itraconazole | ACTIVE_COMPARATOR | - |
| Voriconazole | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Itraconazole | DRUG | Prophylaxis |
| Vfend - voriconazole | DRUG | Prophylaxis |
Inclusion Criteria: * Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML * Male and Female over 12 years or greater Exclusion Criteria: * Possible, probable or proven IFI at study entry or at any time in 6 months prior to stu...
Vfend (voriconazole) is used for antifungal prophylaxis of invasive fungal infections. It is studied in patients receiving allogeneic hematopoietic stem cell transplants, a group at high risk for these infections. Voriconazole is a small molecule antifungal developed by Pfizer, Inc. for infectious disease indications.
Vfend (voriconazole) is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company behind the voriconazole brand Vfend, and it sponsored the clinical trial evaluating the drug in antifungal prophylaxis.
Vfend (voriconazole) has been evaluated in Phase 3 clinical development for antifungal prophylaxis of invasive fungal infections. The Phase 3 trial in this setting is completed, and no trials for this indication are currently active. Voriconazole is a small molecule antifungal agent.
Vfend (voriconazole) was studied in the Phase 3 trial NCT00289991, titled Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT). The trial enrolled 489 participants, was randomized and active controlled, and is completed. It ran in Canada, Czechia, Egypt, France, Greece, Jordan, Portugal, Russia, Spain, Switzerland, Turkey, and the United Kingdom.
Yes, Vfend is the brand name for voriconazole. Vfend and voriconazole refer to the same antifungal small molecule developed by Pfizer, Inc. People searching either name are looking at the same drug, which has been studied in Phase 3 for antifungal prophylaxis of invasive fungal infections.
The Phase 3 trial NCT00289991 compared voriconazole with itraconazole for primary prophylaxis of invasive fungal infection in allogeneic hematopoietic stem cell transplant recipients. It was an active-controlled, randomized study that enrolled 489 participants aged 12 years and older and is completed. It did not use a double-blind design.