New public-private consortium forms to advance lupus treatments

Group will include federal agencies, industry reps, medical societies, scientists, researchers

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by Mary Chapman |

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The Lupus Research Alliance (LRA) has convened a public-private consortium to bring together the U.S. Food and Drug Administration (FDA) and key stakeholders to overcome scientific hurdles in lupus and advance new personalized treatments.

The patient-focused Lupus Accelerating Breakthroughs Consortium (Lupus ABC) will also be made up of other federal agencies, as well as industry representatives, medical societies, scientists, and academic clinical researchers.

“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,” Janet Woodcock, MD, FDA principal deputy commissioner, said in a press release.

Lupus is a chronic condition wherein the immune system attacks healthy tissue. It can affect virtually every part of the body. Because it affects each person differently and its symptoms can evolve over time, the disorder is difficult to diagnose and treat. In the U.S., people of color are two to three times more likely than white people to be diagnosed with it.

“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,” said Teodora Staeva, PhD, LRA’s vice president and chief scientific officer. “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. We are grateful to the FDA for their commitment and support in establishing this crucial partnership.”

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Improving assessment tools, optimizing patient-reported outcomes

The consortium will address impediments to successful clinical trials and work to have the biggest and fastest impact on developing treatments. Efforts will initially seek to:

  • Improve treatment candidate evaluation. Lupus ABC will seek to refine current therapeutic  assessment tools.
  • Integrate patients into treatment development. The consortium will seek to optimize patient-reported outcome measures to recognize prospective therapies’ effects on symptoms of chief concern 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.”

Going forward, consortium members will collaboratively decide its direction and priorities.

“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,” said Nikolay Nikolov, MD, director for the division of rheumatology and transplant medicine at the FDA’s Center for Drug Evaluation and Research. “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 LRA is the largest global nonprofit, nongovernmental funder of lupus research.