Benlysta® Development Facts
About Benlysta (belimumab)
- Benlysta® is the first medicine specifically developed and approved for lupus and the first lupus therapy approved for lupus nephritis.
- It was developed by Human Genome Sciences (HGS) in partnership with GlaxoSmithKline (GSK).
- Benlysta is a human monoclonal antibody that recognizes and inhibits B–cell activating factor (BAFF), also known as B–lymphocyte stimulator (BLyS®), a naturally occurring protein discovered in 1999 by HGS. BAFF is required for the development of B–lymphocyte cells into mature plasma B cells.
- In people with lupus, BAFF is overexpressed, causing autoimmune B cell proliferation and survival. Benlysta binds to BAFF and prevents it from binding to B cells. Without BAFF, B cells die off, preventing an autoimmune reaction.
About the BLISS–LN (Lupus Nephritis) Study
BLISS–LN was a phase III, 104–week, randomized, double–blind, placebo–controlled post–approval commitment study involving 448 patients to evaluate the efficacy and safety of IV belimumab 10 mg/kg plus standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active lupus nephritis.
Major Development Milestones for Benlysta
- February 2007 – HGS and GSK announce the first of two Phase III clinical trials involving patients with serologically active lupus. BLISS–52 and BLISS–76 are multi–center, randomized, double–blind, placebo–controlled studies (52 and 76 weeks in duration) to evaluate belimumab's efficacy and safety. They are the largest randomized placebo–controlled clinical trials ever completed in people with lupus.
- July 20, 2009 – HGS and GSK announce that BLISS–52 had met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo. On November 1, 2009, the companies announced similar positive results for BLISS–76. Both of these trials did not include patients with the most severe forms of lupus, which involve active damage to the kidneys or central nervous system.
- June 9, 2010 – HGS submits a Biologics License Application (BLA) to the FDA for Benlysta.
- August 18, 2010 – The FDA grants Benlysta priority review.
- November 16, 2010 – FDA Arthritis Advisory Committee votes overwhelmingly (13 to 2) to recommend Benlysta for approval.
- March 9, 2011 – FDA approves Benlysta for the treatment of adult patients with active, autoantibody–positive systemic lupus who are receiving standard therapy.
- December 15, 2011 – The companies begin BLISS–SC, a phase III trial to evaluate Benlysta administered subcutaneously (SC) once–weekly.
- July 12, 2012 – GSK begins BLISS–LN, a 104–week study of patients with lupus nephritis treated with Benlysta plus standard of care.
- July 16, 2012 – HGS agrees to be purchased by GSK.
- September 7, 2012 – HGS begins PLUTO (Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy), a 52– week study of Benlysta in children with active systemic lupus.
- November 17, 2015 – GSK announces positive results from the BLISS–SC phase III study.
- July 21, 2017 – FDA approves a new subcutaneous formulation of Benlysta.
- October 23, 2018 – Positive results of the PLUTO study are first presented during the American College of Rheumatology Annual Scientific Meeting.
- April 26, 2019 – FDA approves the use of the intravenous (IV) formulation of Benlysta in children with lupus from as young as five years of age.
- November 28, 2019 – GSK begins recruitment for a 52–week phase III trial to evaluate Benlysta administered subcutaneously (SC) in pediatric patients with systemic lupus.
- December 18, 2019 – GSK announces BLISS–LN achieves primary endpoint and all major secondary endpoints in the phase 3 study of Benlysta in patients with lupus nephritis.
- December 17, 2020 – FDA approved Benlysta for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.