ACTIMMUNE
ACTIMMUNE (interferon gamma-1b) is a Type 2 interferon indicated for the management of two rare inherited disorders, Chronic Granulomatous Disease (CGD) and severe, malignant osteopetrosis (SMO). In patients with CGD, the therapy is used to reduce the frequency and severity of serious infections associated with the condition. For patients with SMO, ACTIMMUNE is utilized to delay the time to disease progression. Both conditions are characterized by specific defects in immune cell function or bone metabolism.
How ACTIMMUNE Works
ACTIMMUNE binds to specific cell surface receptors, triggering a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. This biological activity results in immunoregulation, including the activation of natural killer cells and the enhancement of macrophage oxidative metabolism and antibody-dependent cellular cytotoxicity. In patients with severe, malignant osteopetrosis, the drug has been shown to enhance osteoclast function and phagocyte superoxide production. While the exact therapeutic mechanism for both indicated conditions is not fully established, the drug works by modulating immune response and cellular metabolism.
Details
- Status
- Prescription
- First Approved
- 1999-02-25
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
ACTIMMUNE Approval History
What ACTIMMUNE Treats
2 indicationsACTIMMUNE is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Granulomatous Disease
- Osteopetrosis
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
ACTIMMUNE FDA Label Details
ProIndications & Usage
FDA Label (PDF)ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.