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# FDA Approves GSK’s Subcutaneous Benlysta
- URL: https://www.fdaweb.com/fda-approves-gsks-subcutaneous-benlysta/
- Published: 2017-07-24T12:00:00.000Z
- Updated: 2026-09-14T22:35:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139203

FDA has approved a GlaxoSmithKline supplemental BLA for a new subcutaneous formulation of Benlysta (belimumab) for treating adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE) who are receiving standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease.

  
“After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector,” the company says. Previously, Benlysta was approved in an intravenous formulation and administered by healthcare professionals.