Benlysta FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved March 10, 2011)
Brand name: Benlysta
Generic name: belimumab
Dosage form: Injection
Treatment for: Systemic Lupus Erythematosus; Lupus Nephritis
Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE), and adult patients with active lupus nephritis.
Development Timeline for Benlysta
|Dec 17, 2020||Approval FDA Approves GSK’s Benlysta as the First Medicine for Adult Patients with Active Lupus Nephritis in the US|
|Apr 26, 2019||Approval GSK Receives US Approval of Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above|
|Jul 21, 2017||Approval GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus|
|Mar 10, 2011||Approval FDA Approves Benlysta to Treat Lupus|
|Dec 6, 2010||GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta PDUFA target date to 10th March 2011|
|Nov 17, 2010||Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus|
|Aug 19, 2010||Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for Benlysta (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus|
|Jul 13, 2010||Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for Benlysta, a Potential New Treatment for Systemic Lupus Erythematosus|
|Jun 10, 2010||Human Genome Sciences Announces Submission of Biologics License Application to FDA for Benlysta (belimumab)|
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