April 26, 2019

We are very pleased to share news from GlaxoSmithKline (GSK) that intravenous Benlysta (belimumab) was approved by the U.S. Food and Drug Administration to treat children with lupus who are five years old or above.

The approval was based on data from the ‘PLUTO’ study testing over one year the effectiveness and safety as well as the pharmacokinetics (how the drug moves through the body) of a 10 milligram dose of intravenous belimumab plus standard therapy compared with placebo plus standard therapy among children aged 5 11 years. Disease activity improved in 52.8 percent of children treated with Benlysta plus standard therapy compared with 43.6 percent of those who received placebo and standard therapy. Children who were treated with Benlysta IV plus standard therapy also had a lower risk of a severe flare and a longer period  of time between severe flares (160 days versus 82 days).

Kenneth M Farber, President and CEO, Lupus Research Alliance, commented, “The go-ahead from the FDA for belimumab to be used to treat children with lupus is terrific news for a community desperate for more treatment options. As the only biologic approved for the disease, belimumab has been helping many adults with lupus, and now physicians will have another, much-needed tool for treating their pediatric patients.”

16-year old Maitlyn Fletcher wholeheartedly welcomes this approval. “Diagnosed at 9, I know the toll it takes when you just can’t be a kid because of the symptoms. Lupus has affected me emotionally and physically; I feel like I am always behind everyone else, always catching up because of severe pain and fatigue. My mom and I became involved with the Lupus Research Alliance because they are doing the research that will lead to even more treatments and a cure.”

As noted in the GSK Press Release Benlysta was approved in the U.S. in March 2011 for adults and is currently the only medicine specifically approved in the U.S. for both adults and children with SLE. It is the first time that the FDA has approved a treatment for pediatric patients with SLE.