New York, NY (November 2, 2009) -- The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical landmark - the second positive phase 3 clinical trial of Benlysta (belimumab), the first successfully tested new drug developed specifically for people with systemic lupus.
"This is a pivotal moment in lupus research," said Margaret G. Dowd, president of the LRI, an organization that pioneers discovery in lupus. "It demonstrates the power of innovative science to drive discovery and achieve solid clinical results in the complex autoimmune disease of lupus. Benlysta represents new hope for the 1.5 million Americans with lupus and millions more worldwide who have suffered without a safe and effective treatment for more than 50 years."
"This is spectacular news for the world-wide lupus community," said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago. "These trials demonstrate that SLE can be studied successfully in a clinical trial setting and should encourage further interest in drug development for lupus, an area of great unmet need. Further, these two large, well-designed trials will allow Benlysta, the first biological agent for the treatment of SLE, to be submitted to the FDA for potential approval."
The trial was the second double-blind, placebo-controlled, multi-center study of Benlysta. Known as BLISS-76, the trial enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe.
"Combining the results of this study with the previous successful BLISS-52 study will yield a very large dataset that will allow a better understanding of lupus, the instruments to measure lupus activity, and the responses to treatment," explained Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. "And most important, the two positive trials will allow Human Genome Sciences and GlaxoSmithKline to file for drug approval with regulatory agencies around the world."
"The Benlysta trials are the first well-designed and conducted, comprehensive studies that assessed several measurements of disease," said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. "These trials are a breakthrough for utilizing a methodology that enables researchers to demonstrate disease improvement, and represent a solid path forward for people with lupus."
"As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends HGS and GSK for their commitment and courage in pursuing innovative science, state of the art technology, and smart trial design which has put Benlysta on the road to become the first new drug for lupus that can potentially win FDA approval and start to roll out to physicians and patients," said Dowd.
The LRI funds innovative and creative research to discover new scientific solutions for lupus, and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
"We thank the hundreds of people with lupus who enrolled and took part in these important trials," Dowd said.
To learn more about lupus clinical trials, visit LupusTrials.org.