BENLYSTA is an investigational human monoclonal antibody drug and the first in a new class of drugs called BLyS-specific inhibitors. On March 9, 2011, Human Genome Sciences and GlaxoSmithKline PLC (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved BENLYSTA for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
The label for BENLYSTA includes the following limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.
For full BENLYSTA (belimumab) prescribing information, please click here. For the medication guide for BENLYSTA, please click here.
How BENLYSTA Works
Belimumab blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. BLyS is a naturally occurring protein which was discovered by HGS in 1996.
Collaboration with GlaxoSmithKline
In August 2006, HGS and GSK entered into a co-development and commercialization agreement under which HGS conducted the BENLYSTA Phase 3 trials, with assistance from GSK. The companies share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.
How BENLYSTA Was Discovered
HGS first discovered the naturally occurring protein, BLyS or B-lymphocyte stimulator, in 1996 and published a preliminary description of its activity in the journal, Science, in July 1999. Following that discovery, HGS initiated a program to develop human monoclonal antibodies that would specifically recognize and inhibit the biological activity of BLyS. BENLYSTA is a human monoclonal antibody that HGS generated through a collaboration with Cambridge Antibody Technology.
For More Information about BENLYSTA Clinical Trials
Health professionals and patients interested in BENLYSTA (belimumab) clinical trials or other studies involving HGS products may inquire via email to
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or by calling HGS at (877) 822-8472. Information about HGS clinical trials may also be found at www.clinicaltrials.gov.
To view announcements on BENLYSTA click on the following:
Human Genome Sciences and Glaxosmithkline Initiate Phase 3 Trial of Belimumab (BENLYSTA®) Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus - December 15, 2011
Human Genome Sciences Announces Multiple Abstracts Related to BENLYSTA® and Systemic Lupus Erythematosus to be Presented at the 2011 ACR/ARHP Annual Scientific Meeting - November 4, 2011
GlaxoSmithKline and Human Genome Sciences Receive European Authorization for BENLYSTA® (Belimumab) - July 14, 2011
GlaxoSmithKline and Human Genome Sciences Receive Positive Opinion in Europe from the CHMP for BENLYSTA® (Belimumab) - May 20, 2011
Human Genome Sciences and GlaxoSmithKline Announce FDA Approval of BENLYSTA® (belimumab) for Treatment of Systemic Lupus Erythematosus - March 9, 2011
Human Genome Sciences and GlaxoSmithKline Announce Publication of BLISS-52 Phase 3 Study Results for BENLYSTA® in The Lancet - February 7, 2011
Human Genome Sciences and GlaxoSmithKline Announce FDA Extension of BENLYSTA® PDUFA Target Date to March 10, 2011 - December 3, 2010
Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of BENLYSTA® for Systemic Lupus Erythematosus - November 16, 2010
Human Genome Sciences and Glaxosmithkline Announce FDA Priority Review Designation for Benlysta® (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus - August 19, 2010
Human Genome Sciences Announces Presentation of Additional Phase 3 SLE Study Results for BENLYSTA® (Belimumab) at International Congress on SLE - June 25, 2010
Human Genome Sciences and GlaxoSmithKline Announce Full Presentation at EULAR of BLISS-76 Phase 3 Study Results for BENLYSTA® in Systemic Lupus Erythematosus - June 17, 2010
Human Genome Sciences and GlaxoSmithKline Announce Presentation at EULAR of BLISS-52 Phase 3 SLE Study Results For BENLYSTA® (Belimumab) - June 17, 2010
Human Genome Sciences Announces Submission of Biologics License Application to FDA for BENLYSTA® (Belimumab) - June 10, 2010
Human Genome Sciences Announces Submission of Marketing Authorization Application to EMA for BENLYSTA® (Belimumab) - June 7, 2010
Human Genome Sciences and Glaxosmithkline Announce Topline 76-Week Results of Phase 3 Trial of BENLYSTA™ in Systemic Lupus Erythematosus - April 20, 2010
Human Genome Sciences and GlaxoSmithKline Announce Positive Results in Second of Two Phase 3 Trials of BENLYSTA in Systemic Lupus Erythematosus - November 2, 2009:
Human Genome Sciences and Glaxosmithkline Announce Full Presentation at ACR of Positive Phase 3 Study Results For BENLYSTA™ in Systemic Lupus Erythematosus - October 20, 2009
Novel Evidence-Based Systemic Lupus Erythematosus (SLE) Responder Index Described in Peer Reviewed Publication as Potentially Significant Advance in Lupus Drug Development - September 4, 2009
Human Genome Sciences And Glaxosmithkline Announce Positive Phase 3 Study Results For Benlysta™ In Systemic Lupus Erythematosus - July 20, 2009
Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA™ (formerly Lymphostat-B®) in Patients with Active Systemic Lupus Erythematosus -June 11, 2008
Human Genome Sciences Completes Enrollment in Second Phase 3 Lymphostat-B® Trial -August 27, 2008
Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients with Active Systemic Lupus Erythematosus - June 12, 2008
Human Genome Sciences Completes Enrollment in First of Two Phase 3 LymphoStat-B® Trials - April 22, 2008
Human Genome Sciences Reports Positve Data from Long-Term Treatment with LymphoStat-B in Patients with Active Systemic Lupus Erythematosus - November 9. 2007
Human Genome Sciences Reports that a Phase 2 Study of Lymphostat-B® Showed Significant Reductions in Disease Activity in Patients with Active Systemic Lupus Erythematosus - June 14, 2007
Human Genome Sciences and GlaxoSmithKline Initiate Second Phase 3 Clinical Trial of LymphoStat-B® in Systemic Lupus Erythematosus - May 30, 2007
Human Genome Sciences and Glaxosmithkline Announce Initiation of Phase 3 Clinical Trial of Lymphostat-B® in Systemic Lupus Erythematosus - February 13, 2007
Human Genome Sciences Announces Positive Special Protocol Assessment from FDA for Phase 3 Clinical Trials of Lymphostat-B™ in Systemic Lupus Erythematosus - November 14, 2006
Human Genome Sciences Announces Positive Special Protocol Assessment from FDA for Phase 3 Clinical Trials of Lymphostat-B™ in Systemic Lupus Erythematosus - October 26, 2006
Human Genome Sciences Announces Phase 3 Clinical Development Program for Lymphostat-B™ in Systemic Lupus Erythematosus - August 9, 2006
Human Genome Sciences Announces Full Presentation of Results of Phase 2 Clinical Trial of Lymphostat-B™ in Systemic Lupus Erythematosus - June 22, 2006
Human Genome Sciences Reports Phase 2 Results for Lymphostat-B™ (Belimumab) in Patients with Rheumatoid Arthritis - November 17, 2005
Human Genome Sciences Reports Results of a Phase 2 Clinical Trial of LymphoStat-B™ in Patients with Systemic Lupus Erythematosus - October 5, 2005
GlaxoSmithKline Exercises Option to LymphoStat-B™ - July 7, 2005
Human Genome Sciences Reports Results of a Phase 2 Clinical Trial of LymphoStat-B™ in Patients with Rheumatoid Arthritis - April 6, 2005
Human Genome Sciences Completes Patient Enrollment in a Phase 2 Clinical Trial of Lymphostat-B™ for the Treatment of Rheumatoid Arthritis - July 29, 2004
Human Genome Sciences Completes Patient Enrollment in a Phase 2 Clinical Trial of Lymphostat-B™ for the Treatment of Systemic Lupus Erythematosus - July 29, 2004
Human Genome Sciences Announces Selection of Lymphostat-BTM for Participation in FDA's Continuous Marketing Application Pilot 2 Program - March 4, 2004
Human Genome Sciences Initiates Phase 2 Clinical Trial of Lymphostat-BTM for the Treatment of Rheumatoid Arthritis - January 8, 2004
Human Genome Sciences Reports Results of Phase 1 Clinical Trial of Lymphostat-B™ in Patients With Systemic Lupus Erythematosus - October 28, 2003
Human Genome Sciences Initiates Phase 2 Clinical Trial of LymphoStat-B for the Treatment of Systemic Lupus Erythematosus - September 25, 2003
Results of Phase I Clinical Trial Demonstrate That LymphoStat-B is Safe and Biolocically Active in Patients with Systemic Lupus Erythematosus - April 21, 2003
Human Genome Sciences Initiates Trials of a New Drug for Systemic Lupus Erythematosus and Other Autoimmune Diseases - November 1, 2001
Human Genome Sciences Announces Trial For Treatment of Immunoglobulin-A Deficiency - September 19, 2001
Human Genome Sciences Receives Orphan Drug Designation for BLyS Therapeutic Protein for Treatment of Common Variable Immunodeficiency - February 27, 2001
High Levels of BLyS Implicated in Lupus and Rheumatoid Arthritis Patients - October 30, 2000
Human Genome Sciences and Cambridge Antibody Technology Commit to Exclusive Development of Anti-BLyS Antibodies - October 30, 2000
Human Genome Sciences and Dow Agree To Develop HGS' Radiolabeled B-Lymphocyte Stimulator - October 30, 2000
Human Genome Sciences to Initiate Human Clinical Trials of BLyS - June 23, 2000
Human Genome Sciences Announces the Discovery of a Novel Immune Stimulant - July 8, 1999
