drugset / Trial / NCT03125486
Compassionate Use for Subcutaneous (SC) Belimumab
Summary
GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Timeline
- Start
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- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Belimumab | Monoclonal antibody | 200 mg | Subcutaneous |