Finally—people with lupus and their friends and families are hearing reports of discoveries at the laboratory bench translating into official new treatments.
On March 9th, the U.S. Food and Drug Administration approved Benlysta® (belimumab) for adults with active systemic lupus. Drug developers Human Genome Sciences and Glaxo-Smith-Kline successfully tested the B cell depletion therapy for lupus in large international clinical trials.
The decision was the FDA’s first green light for a safe and effective treatment for lupus in more than half a century, and comes after decades of failures and frustrations in testing drugs for a complex disease that can cause a spectrum of complications.
Benlysta’s success through many stages of bench research, testing, trials, and regulatory approval shows the transformative power of basic, innovative science—and that lupus trials can be worth the time and effort involved.
“This [FDA approval] will give industry as a whole the confidence that it needs to move forward with other therapies,” LRI President Margaret Dowd told the journal Nature Medicine.
Benlysta was developed following the discovery of a new immune system molecule: BLyS. It was found through novel, fundamental science by industry and academia exploring a range of disease pathways and mechanisms—much like the studies the LRI has been supporting for a decade.
“Hopefully the news of Benlysta’s FDA approval will encourage other companies to rededicate themselves to innovation to eventually wipe out the burden of this serious disease,” said Duke University and LRI Scientific Advisory Board member Dr. David S. Pisetsky.
New Trials and Drug Targets
Meanwhile, not only were the Benlysta trials successful, but over 100 other new lupus trials are now moving forward to enrolling participants—see LupusTrials.org for listings—and every year, more drug targets and biomarkers to track changes in disease condition and the effectiveness of therapies are being uncovered.
Thirty percent of LRI scientists who have completed their Novel Research Grants are on the road to translating their research discoveries into patent applications and biomarkers. Pharmaceutical and biotech companies have licensed a number of these and are now developing new agents to test in clinical trials.
New Access to Lupus Diagnosis and Care
Today there’s also new hope for every American with lupus to be diagnosed and properly treated. Through advocacy at the U.S. Department of Health and Human Services (HHS) and in Congress, the LRI’s National Coalition of state and local lupus groups have helped to launch the “Eliminating Health Disparities in Lupus Initiative.”
The goal: to reduce barriers to care through programs to educate physicians and other health professionals about lupus diagnosis and treatment, especially among racial and ethnic minorities, in whom lupus is not only more prevalent but also more severe and even fatal. Nationwide, through various activities including model lupus outreach centers (“Lupus Cooperatives”) in urban centers such as New York City and Los Angeles, Coalition members are finding other ways to increase awareness, support, and access to quality medical care for people with lupus.
The LRI National Coalition was among the first to applaud two new action plans introduced in April and coordinated by HHS and the Office of Minority Health to reduce health disparities among racial and ethnic minorities.
“For the first time, the United States has a coordinated road map designed to give everyone the chance to live a healthy life,” said HHS Secretary Kathleen Sebelius in introducing the plans.
“For the first time in my life, I am very optimistic about the future of lupus research and finding, hopefully, eventually, very soon—a cure for this deadly disease.”
– Heide Wilson after a day on Capitol Hill in mid-March with the LRI National Coalition. Heide not only has lupus herself, but lost a brother to the disease.
Homepage photo: LRI Board Member Hope Hetherington lobbies for lupus research