September 25, 2017
College Park Marriott / Hyattsville, MD

FOR IMMEDIATE RELEASE:

Lupus Groups to Host Patient-Focused Drug Development Meeting

New York, New York and Washington, DC – May 31, 2016 – Today, the Alliance for Lupus Research (ALR),
the Lupus and Allied Diseases Association (LADA), Lupus Foundation of America (LFA), and the Lupus
Research Institute (LRI) announces that a Lupus Patient-Focused Drug Development Meeting – Lupus:
Patient Voices – will be held in spring 2017.

This groundbreaking initiative will culminate in a meeting featuring a series of facilitated panel
discussions designed to provide the Food and Drug Administration (FDA) with perspectives from people
with lupus, advocates and caregivers. Following the successful model FDA developed to host similar
meetings , the day will focus primarily on a range of patient viewpoints on lupus; covering the symptoms
and impacts to daily life that are most important to people with lupus, as well as their perspective on
existing and future treatments. This input can help inform the FDA’s decisions and oversight during drug
development and the review of a marketing application for a new drug.

The four lupus organizations answered 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.

About Lupus
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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Media Contacts:
Denise Prior, the Alliance for Lupus Research, [email protected], 646-884-6055
Megan Vanderbur, the Lupus and Allied Diseases Association, [email protected],
202-656-6684
Tracy Cooley, APR, the Lupus Foundation of America, [email protected], 202-349-1162
Margy Meislin, the Lupus Research Institute, [email protected], 212-685-4118 x 34

Lupus Groups to Host Patient-Focused Drug Development Meeting PDF