Fri, November 20, 2009
Thu, November 19, 2009
Wed, November 18, 2009
Tue, November 17, 2009
Mon, November 16, 2009
Sun, November 15, 2009
Fri, November 13, 2009
Thu, November 12, 2009
Wed, November 11, 2009
Tue, November 10, 2009
Mon, November 9, 2009
Fri, November 6, 2009
Thu, November 5, 2009
Wed, November 4, 2009
Tue, November 3, 2009
Mon, November 2, 2009
Sun, November 1, 2009
Fri, October 30, 2009
Thu, October 29, 2009
Wed, October 28, 2009
Tue, October 27, 2009
Mon, October 26, 2009
Sun, October 25, 2009
Fri, October 23, 2009
Thu, October 22, 2009
Wed, October 21, 2009
Tue, October 20, 2009
Mon, October 19, 2009
Fri, October 16, 2009
Thu, October 15, 2009
Wed, October 14, 2009
Tue, October 13, 2009
Mon, October 12, 2009

Human Genome Sciences and GlaxoSmithKline Announce Positive Results in Second of Two Phase 3 Trials of BENLYSTA(TM) in Systemic


  Copy link into your clipboard //health-fitness.news-articles.net/content/2009/ .. o-phase-3-trials-of-benlysta-tm-in-systemic.html
  Print publication without navigation Published in Health and Fitness on by Market Wire
          šŸž› This publication is a summary or evaluation of another publication

ROCKVILLE, MD and LONDON--(Marketwire - November 2, 2009) - Human Genome Sciences, Inc. (NASDAQ: [ HGSI ]) and GlaxoSmithKline PLC (GSK) today announced that [ BENLYSTA ]ā„¢ (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.

"The BLISS-76 results confirm our view that [ BENLYSTA ] has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We take great pride in the innovation and scientific rigor that has made it possible to bring [ BENLYSTA ] to this point. We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the United States, Europe and other regions. We will continue to work with GSK to advance this drug to the market where it may benefit patients with significant need."

Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, "The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in fifty years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients."

The data from the BLISS-76 study were analyzed after 52 weeks, in accord with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. However, the BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.


Publication Contributing Sources