Novartis has submitted a new drug application (NDA) in China for ianalumab, a first-in-class, fully human monoclonal antibody (mAb) targeting the BAFF receptor (BAFF-R). Acquired through the purchase of MorphoSys, the drug is designed to deplete B cells and inhibit BAFF-R signalling, with potential applications in treating Sjögren's syndrome, immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE). It is the first anti-BAFF-R antibody to complete Phase III studies.

The submission is supported by positive data from three Phase III trials. In the NEPTUNUS-1 and NEPTUNUS-2 studies for Sjögren's syndrome, ianalumab demonstrated a greater reduction in disease activity scores compared to placebo after 48 weeks. In the VAYHIT2 trial for primary ITP, a significantly higher proportion of patients treated with ianalumab in combination with eltrombopag did not experience treatment failure compared to those on placebo.

PharmCube's NextBiopharm® database lists 12 other BAFF-R-targeted antibody-based drugs following in the footsteps of ianalumab.  Click here to request a free trial for NextBiopharm®.