SYNAGIS
Synagis (palivizumab) is a monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients. The therapy is specifically approved for infants with a history of premature birth, as well as children up to 24 months of age with bronchopulmonary dysplasia or hemodynamically significant congenital heart disease. It is used as a preventive measure during the RSV season and is not indicated for the treatment of active RSV disease.
How SYNAGIS Works
Palivizumab is a recombinant humanized monoclonal antibody that acts as a respiratory syncytial virus (RSV) F protein inhibitor. By targeting the F protein on the surface of the virus, the drug provides specific anti-RSV activity to protect the lower respiratory tract. This mechanism prevents the virus from causing serious infection in vulnerable pediatric populations.
Details
- Status
- Prescription
- First Approved
- 1998-06-19
- Routes
- N/A
- Dosage Forms
- VIAL
SYNAGIS Approval History
What SYNAGIS Treats
3 indicationsSYNAGIS is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) who are 6 months of age or younger at the beginning of RSV season.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season.
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.
SYNAGIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of R...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.