China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.
Primary Sjögren’s syndrome (pSS) is a chronic inflammatory autoimmune disease that primarily affects secretory glands, including the lacrimal and salivary glands, and currently lacks effective treatment options. The B cell pathway is critical in the pathogenesis of pSS. Telitacicept is a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), inhibiting B cell maturation and differentiation, reducing autoantibody secretion, and better controlling pSS activity. Phase II study results indicated that telitacicept significantly improved the ESSDAI score and MFI-20 in pSS patients compared to placebo, while also reducing overall immunoglobulin levels and demonstrating a favorable safety and tolerance profile.
Initially conditionally approved in China for the treatment of systemic lupus erythematosus (SLE) in March 2021, telitacicept received full approval in November 2023 and was included in the National Reimbursement Drug List (NRDL) by the end of 2021. The drug is also under evaluation in multiple clinical studies for conditions such as myasthenia gravis and rheumatoid arthritis, in addition to SLE and pSS.- Flcube.com
