Lupus Research Alliance Unites the U.S. Food & Drug Administration (FDA) & Lupus Community to Launch Novel Public-Private Partnership
Lupus Research Alliance Unites the U.S. Food & Drug Administration (FDA) & Lupus Community to Launch Novel Public-Private Partnership

Lupus Accelerating Breakthroughs Consortium to address challenges impacting lupus trial success and to accelerate treatment breakthroughs 

Washington, DC, March 29, 2023 – The Lupus Research Alliance (LRA) today announced the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a first-of-its-kind public-private partnership bringing people with lupus together in collaboration with the U.S. Food and Drug Administration (FDA), other federal agencies, medical societies, industry, academic clinical researchers and scientists to overcome scientific hurdles that are beyond the capacity of any single entity and to advance the development of urgently needed, personalized treatments for lupus.  

Lupus is a complex, potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of color. Lupus can affect the joints, skin, brain, lungs, kidneys, and blood vessels, causing widespread inflammation and tissue damage in the affected organ. A heterogenous disease, lupus affects each person differently and its effects can change over time, making it one of the most difficult diseases to diagnose and treat. Black/African American, Hispanic/Latino, Asian, and Native American populations are two to three times more likely than white Americans to be diagnosed with lupus.  

FDA Principal Deputy Commissioner Janet Woodcock, M.D. commented, “Public-private partnerships such as Lupus ABC can play a critical role in addressing gaps in drug development in a collaborative, pre-competitive setting.  We appreciate the Lupus Research Alliance convening this consortium and bringing together the diverse expertise and perspectives of patients, researchers, regulators, and industry to tackle the most pressing issues in improving therapies for individuals with lupus.” 

 “The clinical development of lupus therapies has long faced major challenges with only three drugs approved specifically for the disease in nearly 70 years. Lupus ABC offers the exciting opportunity to change that by providing a unique forum to address collaboratively scientific and clinical barriers. Inspired by the success of other FDA Public Private Partnerships, the Lupus ABC will enable the faster delivery of new and improved therapies for people with lupus,” said Teodora Staeva, Ph.D., Vice President and Chief Scientific Officer, LRA. “We are grateful to the FDA for their commitment and support in establishing this crucial partnership.”  

 Nikolay Nikolov, M.D., Director for the Division of Rheumatology and Transplant Medicine at the Center for Drug Evaluation and Research, FDA, added, “Our evolving understanding of lupus in recent years makes this an opportune time to work together to address the significant unmet needs of individuals living with lupus, including the disproportionate burden of the disease on racial and ethnic minority communities. We welcome the opportunity to join with the Lupus Research Alliance and the broader lupus community to develop patient-focused tools and approaches and to ultimately advance lupus drug development.”

The Lupus Accelerating Breakthroughs Consortium will provide a forum for the lupus community to define common barriers impeding successful drug development and take actions that will have the greatest and most immediate impact on advancing therapeutic development for lupus. Initially, these efforts will focus on finding ways to:  

  • Better evaluate the impact of potential treatments by refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness. 
  • Fully incorporate the patient voice into the drug development process by optimizing patient-reported outcome measures, enabling recognition of the impact of potential treatments on specific symptoms that matter most to patients. 

“The Lupus Accelerating Breakthroughs Consortium will, for the first time, truly give people who live with lupus and their caregivers a platform where they can be heard and involved in the treatment development process directly with all stakeholders,” said Veronica Vargas Lupo, co-lead of the Consortium’s Lupus Voices Council. “As someone who has lived with the disease for many years and knowing the wide range of symptoms that those of us with lupus experience, having a voice in this process is immensely important. It is so critical for our perspectives to be considered when designing clinical trials and measuring outcomes to develop tailored therapies in lupus.”   

Lupus ABC is a response to the urgent and unmet needs in lupus therapies and a commitment to pursue better treatments, and ultimately, a cure, for people with lupus. The direction and priorities for the effort will be determined with input from all partners.  For more information about the Consortium, visit LupusABC.org.  

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, 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. Visit LupusABC.org to learn more.  

Read Statement from the U.S. Food and Drug Administration

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