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  1. Drug Safety and Availability

FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance

[3/29/2023] FDA’s Center for Drug Evaluation and Research has partnered with the Lupus Research Alliance (LRA) to launch the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a first-of-its-kind public-private partnership focused on addressing challenges impacting lupus clinical trial success.  

Lupus ABC will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to address scientific hurdles that are beyond the capacity of any single entity. By connecting those with lived experience with all parties involved in lupus treatment research, CDER hopes to advance the development of urgently needed treatments for lupus.  

Lupus is a complex, potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of color. The disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels, causing widespread inflammation and tissue damage in the affected organ. Lupus affects each person differently, and its effects can change over time, making it one of the most difficult diseases to diagnose and treat.  

Lupus ABC will provide a forum to define common challenges in drug development and facilitate approaches that will have the 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 direction and priorities for the effort will be determined with input from all partners. For more information about the Consortium, visit LupusABC.org. 

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