VIGPODER
Details
- Status
- Prescription
- First Approved
- 2022-06-24
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
VIGPODER Approval History
What VIGPODER Treats
2 indicationsVIGPODER is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complex Partial Seizures
- Infantile Spasms
VIGPODER Boxed Warning
PERMANENT VISION LOSS VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGPODER is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from VI...
WARNING: PERMANENT VISION LOSS VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGPODER is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from VIGPODER are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGPODER), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to VIGPODER is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. Risk of new or worsening vision loss continues as long as VIGPODER is used. It is possible that vision loss can worsen despite discontinuation of VIGPODER. Because of the risk of vision loss, VIGPODER should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for VIGPODER should be periodically reassessed. VIGPODER should not be used in patients with, or at high risk of, other types of irreversible vision loss unless t
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIGPODER FDA Label Details
ProIndications & Usage
VIGPODER is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGPODER is not indicated as a first line agent Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss 1.1 Refractory Complex Partial Seizures (CPS) VIGPODER is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inad...
WARNING: PERMANENT VISION LOSS VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The ons...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.