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GlaxoSmithKline boost for Benlysta

The latest phase III trial for Benlysta (belimumab) has shown a significant improvement in patients with systemic lupus erythematosus (SLE) or lupus

The latest phase III trial for Benlysta (belimumab) has shown a significant improvement in patients with systemic lupus erythematosus (SLE) or lupus.

GlaxoSmithKline (GSK) and its partner, Human Genome Sciences, say that Benlysta met its primary endpoint and was well tolerated. It is estimated that approximately 50,000 people have lupus in the UK. 

The Lupus Research Institute (LRI), based in New York, and its national coalition of US state and local lupus organisations have referred to the results as an historical landmark. Benlysta is 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. "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 1.5m 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, and 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."

"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."

2nd November 2009

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