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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 with protracted pediatric-onset systemic lupus
erythematosus (SLE) who has been receiving belimumab administered intravenously (IV) for her
SLE since August of 2013. The subject has comorbidities including end-stage renal disease
requiring hemodialysis, osteoporosis and fibromyalgia. The subject had responded positively
to belimumab IV, however, due to the deterioration of her condition, the subject now lacks
venous access and can no longer receive IV infusions. Given her lack of venous access,
documented positive response to belimumab administered IV, and current disease condition
requiring continued treatment, she is an appropriate candidate for SC belimumab
(compassionate use).
In this study, The intended 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. For this subject, 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.