Lupus Research Alliance, FDA partner to counter challenges in lupus drug development
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Key takeaways:
- Lupus ABC aims to connect patients with government officials, medical societies, industry representatives and researchers.
- Efforts will include promoting patient perspectives.
The Lupus Research Alliance and the FDA have announced a public-private partnership to increase collaboration and further the advancement of personalized therapies for lupus.
“We are here today for one simple reason: Lupus drug development is hard,” Albert Roy, president and CEO of the Lupus Research Alliance (LRA), said during a webinar announcing the partnership. “Lupus is a complex disease that affects every person differently, and its effects wax and wane over time, which makes it one of the most difficult diseases to diagnose and treat, let alone commercialize life-changing therapies.”
The Lupus Accelerating Breakthroughs Consortium — or Lupus ABC — aims to connect patients who have lupus with other stakeholders and policymakers, including government groups, medical societies, industry representatives and clinical researchers, to advocate for and make progress toward personalized treatments.
“The Lupus ABC was formed for precisely this reason — to increase the speed with which new therapies can be made available to our patients,” Gary Koretzky, MD, PhD, a professor of medicine at Weill Cornell Medicine, and the co-chair of the Lupus ABC Research Committee, told attendees at the webinar. “It is increasingly clear that one of the major hurdles is that the way we enroll patients in trials and how we evaluate outcomes needs to be re-imagined.”
According to Koretzky, most people likely view lupus less as a single entity and more as a “constellation of diseases.” The resulting need is one of personalized outcome measures that will have a better chance at determining the success of therapies in the development pipeline.
To identify the obstacles to drug development as viewed by the patient community, the consortium will host forums to allow stakeholders to connect. The first topics of interest, according to the LRA, include improving current research measurement tools to more adequately describe a therapy’s merits, and highlighting patient voices to improve patient outcome measures.
“The Lupus ABC emerged from three key initiatives, or influences,” Teodora Staeva, PhD, the chief science officer of the LRA and the Lupus ABC coordinating lead to the FDA, said during the webinar. “One is the urgent need to address the longstanding challenges in lupus drug development; two is the requirement to integrate the patient perspective in this process; and three is the lupus community’s desire and commitment to deliver safer and more effective treatment options for individuals with lupus.”
The first meeting between the Lupus ABC, the FDA and “other stakeholders” will take place from April 16 to 17 in Washington, D.C., Roy said.
“Lupus ABC is a response to the urgent, unmet needs in lupus therapies and a commitment to pursue better treatments and, ultimately, a cure for people with lupus,” the LRA said in a press release. “The direction and priorities for the effort will be determined with input from all partners.”
References:
Lupus research alliance unites the U.S. Food and Drug Administration (FDA) & Lupus Community to Launch Novel Public-Private Partnership. https://www.lupusresearch.org/lupus-research-alliance-unites-the-u-s-food-drug-administration-fda-lupus-community-to-launch-novel-public-private-partnership/. March 29, 2023. Accessed March 29, 2023.
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