The U.S. Food and Drug Administration (FDA) 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 recombinant protein, made in the lab with parts of naturally produced human proteins that blocks both lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL).
By blocking these molecules, the experimental therapy aims to suppress the development and survival of plasma cells and mature B-cells, which produce the autoantibodies that attack tissues in autoimmune diseases. RC18 has little impact on early and memory B-cells, which are important for immune defense.
For further information on RC18 please click here.
