The board of directors of the RemeGen Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted telitacicept a fast track designation (FTD) for the treatment of patients with primary Sjögren's Syndrome (pSS). At the end of 2023, FDA approved the investigational new drug (IND) application for a Phase III trial of telitacicept for the treatment of patients with pSS. Fast track designation is an FDA policy for expedited review of clinically urgent products designed to streamline the development and accelerate the review of innovative drugs with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need.

A drug candidate that receives the designation is eligible for more frequent communication and interaction with the FDA, potentially leading to accelerated approval. Previously, the results of a randomized, double-blind and placebo-controlled Phase II clinical trial of telitacicept for the treatment of patients with pSS in China were published in RHEUMATOLOGY, a leading international journal. The conclusion of the study suggested that telitacicept demonstrated a favorable clinical benefit in the treatment of patients with pSS.

Compared with placebo, the telitacicept treatment group significantly improved ESSDAI scores and MFI-20 scores and reduced immunoglobulin levels in patients with pSS at weeks 12 and 24, was safely tolerated without serious adverse events, and there were no deaths in any of the groups during the trial period.