August 31, 2021, New York, NY— The National Kidney Foundation (NKF) in partnership with the NephCure Kidney International, Inc. (NephCure) hosted a gathering of patients and care partners to share with the U.S. Food and Drug Administration (FDA) their experience with a rare kidney disease, membranous nephropathy (MN).
At this Externally Led Patient-focused Drug Development Meeting (EL-PFDD), which was held virtually on August 27, 2021, dozens of patients were invited to speak directly to the FDA about their daily life with MN and conveyed their needs for medicines to treat the disease. Patients voiced the physical, cognitive, and psychosocial effects of the disease and what created the most frequent impacts on daily life. Some shared their desire for safe, effective drugs to maximize chances for remission and halt progression of the disease.
The FDA invites organizations to hold such meetings to gain patient perspective and aspirations for future drug treatments as it considers the merits of potential new treatments submitted for approval.
In the months following the meeting, NKF and NephCure will create a Voice of the Patient report summarizing the meeting for the FDA. The report will be presented next year.
“This EL-PFDD meeting on membranous nephropathy is an important event for the MN community,” said NKF Senior Vice President of Strategic Partnerships Anthony Gucciardo. “The FDA and pharma companies that are developing drugs for this disease hear directly from MN patients and care-partners. Everyone wins in this scenario.”
The FDA has participated in dozens of EL-PFDD meetings to help them inform drug approval decisions on a range of diseases. This was the fifth time NKF has hosted an EL-PFDD meeting on a kidney disease and the second in partnership with NephCure.
In addition to patients and FDA staff, nephrologists, pharmaceutical representatives, researchers, and other stakeholders heard first-hand the experiences of patients who have this disease. About 100 people in total attended the virtual event.
MN damages the kidneys’ filters and leads to excessive amounts of protein in the urine. This causes swelling (edema) around the eyes, ankles, and legs that can sometimes be very painful. MN patients also endure extreme fatigue. Some patients experience multiple remissions and relapses of the disease. In the more progressive cases, MN can lead to kidney failure.
Once the final report of the meeting is completed and submitted to the FDA, it will be available to the public for reading.
NephCure is an organization that supports research for effective treatments for rare forms of Nephrotic Syndrome, and provides education and support that will improve the lives of those affected by these protein-spilling kidney diseases.
Kidney Disease Facts
In the United States, 37 million adults are estimated to have chronic kidney disease (CKD)—and approximately 90 percent don’t know they have it. 1 in 3 adults in the U.S. is at risk for chronic kidney disease. Risk factors for kidney disease include: diabetes, high blood pressure, heart disease, obesity, and family history. People who are Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, or Native Hawaiian or Other Pacific Islander are at increased risk for developing the disease. Black or African American people are almost 4 times more likely than Whites to have kidney failure. Hispanic or Latino people are 1.3 times more likely than non-Hispanic or non-Latino people to have kidney failure.
About the National Kidney Foundation
The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.