Decision Could Help Potential SLE Treatment Reach People Living With Lupus Sooner
The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Fast Track designation for nipocalimab in development by Johnson & Johnson for the treatment of adults with systemic lupus erythematosus (SLE) – a chronic autoimmune disease for which there are few treatment options. The FDA grants this designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need” – with the goal of reaching patients earlier.
“Because SLE manifests so differently from one person to the next, advancing an array of treatment options continues to be paramount,” Albert T. Roy, President & CEO of the Lupus Research Alliance, said. “It is encouraging to see progress in personalized treatments – especially those with the potential to reduce reliance on steroids. This designation from the FDA signals continued momentum for the millions of people impacted by lupus worldwide.”
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions. As reported in a press release issued by Johnson & Johnson, the Fast Track designation was granted based on positive data from the Phase 2b JASMINE study showing improved disease activity and lowered steroid use among adults with active SLE.
Enrollment has begun for the Phase 3 GARDENIA study of adults with active SLE.
Johnson & Johnson is a member of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), convened by the Lupus Research Alliance as a public-private partnership with the FDA that focuses specifically on advancing the development of safer and more effective treatments urgently needed for people with lupus.
About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body’s own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15–45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus.
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 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 funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
For more information or to donate to lupus research, visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram.
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Media Contact:
Rebekah Barnes
RBarnes@lupusresearch.org
Tags: treatment, FDA, U.S. Food and Drug Administration, Fast-track designation, Johnson & Johnson, SLE, systemic lupus erythematosus