PULMOZYME
Pulmozyme (dornase alfa) is a recombinant human deoxyribonuclease 1 indicated for the management of cystic fibrosis in both pediatric and adult patients. Used in conjunction with standard therapies, the medication is intended to improve pulmonary function and reduce the risk of respiratory tract infections requiring parenteral antibiotics in specific patient populations. It addresses the clinical challenges associated with the retention of viscous purulent secretions in the airways.
How PULMOZYME Works
Pulmozyme is a recombinant human deoxyribonuclease I enzyme that functions by selectively cleaving DNA. In cystic fibrosis patients, purulent pulmonary secretions contain high concentrations of extracellular DNA released by degenerating leukocytes. The enzyme hydrolyzes this DNA to reduce the viscoelasticity of the sputum, addressing the secretions that contribute to reduced pulmonary function and exacerbations of infection.
Details
- Status
- Prescription
- First Approved
- 1993-12-30
- Routes
- N/A
- Dosage Forms
- VIAL
PULMOZYME Approval History
What PULMOZYME Treats
2 indicationsPULMOZYME is approved for 2 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystic Fibrosis
- Respiratory Tract Infection
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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.
PULMOZYME FDA Label Details
ProIndications & Usage
FDA Label (PDF)PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.