The mission of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) is to unite individuals with lupus and their advocates, industry, clinicians, researchers, and government stakeholders to identify and pursue the most effective ways to accelerate lupus drug development in a collaborative, pre-competitive setting.
Our Challenge
Lupus is complex.
Lupus is a heterogeneous disease – it presents many symptoms that vary from person to person, and symptoms can even change over time. This makes lupus especially difficult to diagnose and treat, which impacts patients’ quality of life and long-term survival. There have also been major challenges to the development of safe, effective, and tailored treatments to improve these outcomes.
The extraordinarily high rate of failed lupus trials has led to a consensus among experts that current endpoint measures – how safety and effectiveness of potential treatments are evaluated – and trial designs may be unable to capture meaningful data on a drug’s effects. Furthermore, physician-assessed outcome measures do not include certain outcomes that are most important to people with lupus.
Additionally, there is a continuing need to better incorporate and elevate patient voices in the current approach to lupus therapeutic development. This is especially true for minority populations who are impacted most severely by the disease. This perspective is fundamental to the ability to execute successful trials and ultimately provide benefits to people with lupus with the highest unmet need.
Our Opportunity
There is a robust pipeline of tens of lupus treatments currently being tested. There are also rich data from previous failed trials that add new insights and advance our ability to design better trials. The lupus community is ready to work in partnership with the FDA to ensure potential new lupus drugs can be effectively evaluated and rapidly approved. Together, we will deliver a modern approach that ensures safer and more effective treatment options for people living with lupus.
The Lupus Accelerating Breakthroughs Consortium Will
1
Bring the experiences, perspectives, needs, and priorities of people with lupus into the spotlight as a key partner in developing new lupus treatments.
2
Enable open collaboration between key stakeholders and regulators to develop and pursue initiatives that have the highest potential for improving the health outcomes of individuals with lupus.
3
Identify and pursue the most effective ways to accelerate lupus drug development.
4
Convene workshops, produce white papers, and publish articles that could inform updated guidance on lupus drug development.
A Path of Progress
For decades, lupus treatments remained limited. The field has experienced unprecedented progress – due to the innovation, collaboration, and dedication of researchers, clinicians, industry, advocates, and people living with lupus.
See the momentum driving us toward greater breakthroughs.
1948-1955
For decades, lupus treatments were largely limited to symptom-management medications like aspirin and corticosteroids, alongside the repurposed drug hydroxychloroquine, which received expanded approval from the U.S. Food and Drug Administration (FDA) to treat the disease.
Focus shifted to developing treatments that specifically target the underlying mechanisms driving lupus.
2011
TREATMENT UPDATE: Benlysta® approved by the U.S. FDA to treat lupus.
2015
A federal working group on lupus called for the creation of a public-private partnership to develop a precision medicine approach to treating and preventing the disease.
2017
The U.S. FDA brought together lupus leaders for its Lupus Patient-Focused Drug Development (PFDD) meeting. During this event, the group emphasized the role of people living with lupus and incorporating their voices in the foundation of therapeutic development.
2020
TREATMENT UPDATE: Benlysta® expanded approval by the U.S. FDA to treat lupus nephritis.
2021
TREATMENT UPDATE: Lupkynis® approved by the U.S. FDA to treat lupus nephritis.
TREATMENT UPDATE: Saphnelo® approved by the U.S. FDA to treat lupus.
2023
The Lupus Research Alliance introduces the Lupus Accelerating Breakthroughs Consortium (Lupus ABC).
The Lupus ABC is the only public-private partnership with the U.S. FDA that focuses specifically on advancing the development of safer and more effective treatments urgently needed for people with lupus.
2025
TREATMENT UPDATE: Gazyva® approved by the U.S. FDA to treat lupus nephritis
Lupus is complex and heterogeneous. Working together, we can accelerate the breakthroughs that people living with lupus urgently need.