Approved for patients
as young as 5 years old


Ask your doctor about BENLYSTA, the first FDA-approved treatment for lupus in over 50 years.

In 2011, BENLYSTA became the first prescription treatment in over 50 years to be approved for adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. In 2017, a subcutaneous (SC) administration method was approved by the U.S. Food and Drug Administration (FDA).

BENLYSTA is not a steroid – it's a biologic therapy, delivered either through an intravenous (IV) infusion or as a subcutaneous (SC) self-injection. It works by reducing certain cells in your immune system that can make lupus active.

In adult clinical trials, BENLYSTA plus other medicines commonly used to treat lupus were superior to those medicines used alone in reducing lupus disease activity.

Benefits of BENLYSTA

When added to other medicines commonly used to treat lupus, compared to those medicines used alone, BENLYSTA has been shown to:


Mainly due to improvements in the:
Immune System | Muscles | Mouth | Joints | Skin

To learn more about BENLYSTA, click here


Reduction in the risk of severe flares occurred in two of the three clinical trials.

Quick Facts


  • a biologic, not a steroid
  • taken in addition to your other lupus medications
  • available in three options:
    • an autoinjector you self-inject
    • a prefilled syringe you self-inject
    • an intravenous infusion your healthcare provider administers
  • the first lupus treatment approved by the FDA in over 50 years

Patient Experience

Real patients from our lupus community discuss how they felt about the possibility of receiving treatment with BENLYSTA.

View more patient stories

History of BENLYSTA


Researchers identify a naturally occurring protein in the human body called BLyS (pronounced "bliss"), short for B-lymphocyte stimulator. Clinical studies show a connection between higher levels of BLyS and lupus disease activity in some people.

Phase III clinical trials for BENLYSTA IV begin.
BENLYSTA becomes the first FDA-approved medication in over 50 years to treat adults with active lupus. BENLYSTA binds to BLyS and changes to reduce lupus disease activity. It is the first in a drug class known as BLyS-specific inhibitors.
FDA approves BENLYSTA for subcutaneous (SC) self-injection in addition to the intravenous (IV) infusion option.