Compassionate Use Program For Subcutaneous (SC) Belimumab

GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the SC
formulation of belimumab which is currently under review by the Food and Drug Administration
(FDA). The goal of this individual subject compassionate use program is to provide a subject
with SC belimumab for the period of 1 year or until the SC formulation of belimumab becomes
approved for use by the FDA and is commercially available to this subject, whichever is
sooner. GSK will supply SC belimumab 200 milligram (mg) pre-filled syringes for
compassionate use in the identified individual subject. In this study, the regimen for SC
belimumab is 200 mg weekly to be administered by the subject at home. Treatment with SC
belimumab is expected to be ongoing and the subject's clinical status will be monitored
regularly. The benefit versus risk will be assessed throughout the study to support
continued treatment with SC belimumab. The need for continuation of this program will be
assessed by GSK at 1 year from the initiation of dosing or if approved, when the drug
becomes commercially available to this subject.