Benlysta FDA Approval History
Last updated by Judith Stewart, BPharm on May 21, 2024.
FDA Approved: Yes (First approved March 10, 2011)
Brand name: Benlysta
Generic name: belimumab
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: 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
Date | Article |
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May 20, 2024 | Approval FDA Approves Benlysta (belimumab) Autoinjector for Children with Systemic Lupus Erythematosus |
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) |
Further information
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