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GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment

Neha Gupta

2 min read

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GSK plc (NYSE:GSK) is one of the 11 best European stocks to invest in. On June 24, the company announced receipt of FDA approval for a 200 mg/mL autoinjector of Benlysta (belimumab) for the treatment of active lupus nephritis (LN). The approval applies to children aged five years and above.

GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment

GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment

A pharmacist looking at a prescription bottle of gastrointestinal drugs.

Benlysta autoinjector is the first-of-its-kind treatment option for at-home administration. The drug is a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody. It works by binding to soluble BLyS, which inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. It does not bind B cells directly.

The 200 mg/mL autoinjector was previously approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Benlysta was the first and only approved biologic for both SLE and lupus nephritis in over 50 years, including for the pediatric population. The autoinjector will be available for patients and their caregivers immediately.

GSK plc (NYSE:GSK) is a UK-based global biopharmaceutical company. It researches, develops, and sells medicines and vaccines for infectious diseases, HIV, respiratory conditions, cancer, and immune-related disorders. Its key products include Shingrix (shingles vaccine), Nucala (asthma), and HIV treatments through its ViiV Healthcare joint venture.

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Disclosure: None.