Benlysta is a human monoclonal antibody that was approved for the treatment of lupus in adults by the U.S. Food and Drug Administration (FDA) in 2011 and for lupus nephritis in adults in 2020.

The approval makes belimumab (Benlysta) the first at-home treatment in its class for patients 5 years and older with systemic lupus erythematosus (SLE). The FDA approved GSK’s belimumab (Benlysta) ...

The 200mg single-dose prefilled autoinjector allows pediatric patients to receive SLE treatment at home via SC administration. The Food and Drug Administration (FDA) has approved Benlysta (belimumab) ...

Benlysta is an immunosuppressant medication that can lower the amount of antibodies your immune system produces. This makes it effective in managing different forms of lupus. Benlysta works by ...

MONDAY, June 30, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active ...

Benlysta (belimumab) is a prescription drug that’s used to help manage certain types of lupus. It’s not known whether Benlysta is safe to use while pregnant or breastfeeding. If you can become ...

The U.S. Food and Drug Administration has approved GSK's autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving ...

Belimumab autoinjector is now approved and available for pediatric patients with lupus nephritis. The US Food and Drug Administration (FDA) has approved the belimumab 200 mg/mL autoinjector for ...

GlaxoSmithKline (GSK) is running a post‑marketing study titled “BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation.” The goal is to track how safe and effective ...

The U.S. Food and Drug Administration has approved GlaxoSmithKline's 200-mg subcutaneous route of administration of Benlysta (belimumab) for patients 5 years of age and older with active systemic ...

The U.S. Food & Drug Administration (FDA) has granted approval for a novel and less invasive belimumab (Benlysta®) treatment for children with systemic lupus erythematosus (SLE) ages five years and ...