Benlysta FDA Approval History
Last updated by Judith Stewart, BPharm on July 27, 2022.
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 for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis.
Benlysta is indicated for the treatment of:
- patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy;
- patients aged 5 years and older with active lupus nephritis who are receiving standard therapy.
Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Use of Benlysta is not recommended in this situation.
Development timeline for Benlysta
|Jul 27, 2022||Approval GSK Announces US FDA Approval of Benlysta (belimumab) for Pediatric Patients with Active Lupus Nephritis|
|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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