New Phase 3 Study Shows Positive Results for Benlysta® in Lupus Nephritis

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Dec 18, 2019, 09:07 ET

NEW YORK, Dec. 18, 2019 /PRNewswire/ -- The Lupus Research Alliance is encouraged by exciting news from GSK that Benlysta® (belimumab) demonstrated positive clinical trial results in treating lupus nephritis (LN), a common complication of lupus causing inflammation of the kidneys that can result in end-stage kidney disease. Called BLISS-LN, this trial is the largest one ever conducted among patients with lupus nephritis and paves the way for a new treatment for lupus nephritis.

Although belimumab is already approved by the U.S. FDA to treat systemic lupus erythematosus (SLE), it had not been tested in patients specifically for lupus nephritis and has not yet been approved for this use. The BLISS-LN trial is the last stage in clinical development before GSK submits its data with a formal request for the FDA to approve the drug as a treatment for lupus nephritis. The company expects to file with the FDA in the first half of 2020.

Kenneth M. Farber, President and CEO of the Lupus Research Alliance said: "We are very gratified that at long last additional treatment options may be emerging for lupus nephritis. Belimumab is the only drug specifically developed and approved for lupus in decades, and the fact that it has shown benefit, not only for generalized SLE, but also now for lupus nephritis, is great news. GSK has long been a terrific partner to the Lupus Research Alliance, and we extend our congratulations as well as appreciation to GSK, to the investigators who enrolled patients in the study, and especially to the people with lupus who generously participated."

As background, belimumab, like all drugs reviewed by the FDA, went through extensive clinical trials to test for safety and efficacy. Phase I studies test a drug's safety in a small number of healthy people and establish dosing, and Phase II studies test the drug's effectiveness in patients and monitor safety. Phase 3 studies test the drug in a large group of patients with randomized, double-blinded trial designs. That means people are randomly selected to receive the drug being tested or placebo, and no one knows who received what until the end of the study. Phase 3 studies compare the new treatment plus the standard of care (the treatment most accepted in medical practice) versus placebo plus standard of care. Companies submit filings of their data to the FDA for review after the Phase 3 trials are completed.

"We encourage people with lupus and their families to visit our website LupusTrials.org and learn about clinical research. Talk to your doctor and see if there's a study that's right for you. Your participation is critical – we can't deliver new treatments without your help," continued Mr. Farber.

About Lupus

Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women, most of whom are diagnosed between the ages of 15 to 44. Women of color are especially at risk. In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body's own tissues and organs -- the kidneys, brain, heart, lungs, blood, skin, and joints.

About the Lupus Research Alliance

The Lupus Research Alliance is transforming the lives of people affected with lupus by financing the most innovative lupus research in the world. The organization's stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance's Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

SOURCE Lupus Research Alliance