The four lupus organizations answered the FDA's call for groups to submit a Letter of Intent (LOI) to the FDA requesting to host an externally-led Patient Focused Drug Development (PFDD) meeting. The FDA recently accepted the LOI for lupus. This meeting will give the lupus community an opportunity to share insights that have the potential to be helpful to the process of developing new treatments for the disease.
This fall, the organizations will begin to gather input from people with lupus across the country through surveys and personal stories. At that time, information on how to participate will be made widely available throughout the national lupus community.
Lupus is a chronic autoimmune disease that causes inflammation and tissue damage to virtually any organ system in the body. The health effects of lupus can include heart attacks, strokes, seizures, organ failure and possible death. By the most conservative estimates, there are at least 322,000 Americans with definite or probable lupus, with independent surveys suggesting an estimated 1.5 million people affected.
About the PFDD Initiative
For more information about the Externally-Led PFDD Initiative Meetings, visit FDA.gov.
About the Hosting Organizations
For more information about the Alliance for Lupus Research, visit lupusresearch.org
For more information about the Lupus and Allied Diseases Association, visit NoLupus.org
For more information about the Lupus Foundation of America, visit lupus.org
For more information about the Lupus Research Institute, visit lupusresearchinstitute.org
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SOURCE ALR, LADA, LFA, LRI