> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# RemeGen Gets Fast Track for Lupus Drug
- URL: https://www.fdaweb.com/remegen-gets-fast-track-for-lupus-drug/
- Published: 2020-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:11:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146577

FDA has granted RemeGen a fast track designation for RC18, a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein for treating systemic lupus erythematosus. The chronic autoimmune disease attacks healthy tissue and affects upwards of 1.5 million people in the U.S. The company says the drug, which has a novel dual-target mechanism, has shown statistically significant improvement for patients at multiple doses. It works by inhibiting the development and survival of plasma cells and mature B cells that are implicated in several autoimmune diseases. The drug is also being studied in rheumatoid arthritis and Neuromyelitis Optica Spectrum Disorder.

“RC18 works by binding to two cell-signaling molecules, B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL),” the company says. “By only affecting mature B cells, RC18 has minimal impact on early and memory B cells, which are important for normal body immune function.”