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LRA Congratulates GSK on FDA Approval of Benlysta® (belimumab) for Children with Lupus Nephritis

Key Takeaway: The FDA has approved belimumab (Benlysta®) as the first treatment for children aged 5 to 17 with lupus nephritis, marking a significant advancement in pediatric lupus care. The Lupus Research Alliance celebrates this milestone, highlighting their role in funding the research that contributed to the drug's development.
Price reaction · baseline $42.16 (2022-07-25 close) · hit after-hours · clean, no other GSK news in the window
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POSITIVE FACTORS

  • FDA approval of belimumab for children with lupus nephritis
  • First-ever treatment specifically indicated for children
  • Community celebration for the approval
  • Funding of original research leading to drug's development

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Full Press Release Details

NEW YORK , July 27, 2022 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to share that the U.S. Food and Drug Administration (FDA) has approved belimumab (Benlysta®) as the first-ever treatment specifically indicated for children aged 5 to 17 with lupus nephritis. Belimumab is already approved by the FDA to treat lupus nephritis in adults as well as lupus in the pediatric population.
When proteins produced by the immune cells called antibodies attack the kidney tissue, inflammation, or lupus nephritis results. Eight out of ten children with lupus will have kidney damage, which usually stems from lupus nephritis. When the kidneys become inflamed, they can't effectively get rid of waste products and other toxins from the body. This can lead to end-stage kidney disease which can require dialysis to remove waste products mechanically or a kidney transplant.
"Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis," commented Lupus Research Alliance President and CEO Kenneth M. Farber . "We are particularly proud to see belimumab approved to help yet another patient population, having funded much of the original research that led to the drug's development."
Lupus nephritis has been a primary focus of lupus research since the organization's inception and continues with substantial investment going to improve diagnosis, monitoring, and treating the condition.
Click here for the announcement from GSK.
About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Hispanic Americans, Asian Americans and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and 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

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