Compassionate Use for Subcutaneous (SC) Belimumab

Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2017

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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.
Epistemonikos ID: 8101be8ae4a2adce124dd8be30ad630a20d5ea7c
First added on: May 20, 2024