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Benlysta Approval History

  • FDA approved: Yes (First approved March 10th, 2011)
  • Brand name: Benlysta
  • Generic name: belimumab
  • Dosage form: Injection
  • Company: Human Genome Sciences, Inc. and GlaxoSmithKline
  • Treatment for: Systemic Lupus Erythematosus

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus.

Development History and FDA Approval Process for Benlysta

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)

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