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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
Company: GlaxoSmithKline
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

DateArticle
Dec 17, 2020Approval  FDA Approves GSK’s Benlysta as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Apr 26, 2019Approval  GSK Receives US Approval of Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above
Jul 21, 2017Approval  GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus
Mar 10, 2011Approval  FDA Approves Benlysta to Treat Lupus
Dec  6, 2010GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta PDUFA target date to 10th March 2011
Nov 17, 2010Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus
Aug 19, 2010Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for Benlysta (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus
Jul 13, 2010Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for Benlysta, a Potential New Treatment for Systemic Lupus Erythematosus
Jun 10, 2010Human Genome Sciences Announces Submission of Biologics License Application to FDA for Benlysta (belimumab)

Further information

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