LRA Salutes RemeGen on FDA Fast-Track Designation for Potential Lupus Treatment

April 16, 2020

The Lupus Research Alliance is pleased to share news that promises to speed up testing and review of a potential new treatment for lupus.  The U.S. Food and Drug Administration granted fast-track designation to RC18, in development by a company in China, RemeGen.

The FDA defines fast track as “a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.”

RC18 is a novel protein with a dual-targeting mechanism that inhibits the development and survival of certain cells involved in autoimmune diseases such as lupus.

“SLE is a chronic autoimmune disease which attacks healthy tissue,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen. “With no cure, SLE is estimated to affect between 322,000 and 1.5 million people in the US.  With limited treatment options available for patients, the Fast Track designation gives RemeGen the opportunity to help those impacted by offering a therapy with first-in-class and best-in-class potential.”

“More treatment options are critically needed for lupus,” noted Lupus Research Alliance Chief President and CEO Kenneth Farber.  “We continue to watch the progress of RC18 with great interest and hope that it may offer a new tool for physicians to help their patients manage their disease.”

About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latin Americans, Asian Americans and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.

About the Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus.  Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

RC18 is a novel protein with a dual-targeting mechanism that inhibits the development and survival of certain cells involved in autoimmune diseases such as lupus.

Read RemeGen Press Release