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Novartis Ianalumab Meets Efficacy and Safety Goals in Phase 3 Sjögren’s Trials

The trial success paves the way for regulatory submissions, positioning the drug as the first targeted therapy to modify Sjögren’s disease course.

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Overview

  • In the NEPTUNUS-1 and NEPTUNUS-2 Phase 3 trials, ianalumab achieved statistically significant improvements in disease activity versus placebo as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
  • The antibody was well tolerated and demonstrated a favorable safety profile across both studies.
  • Ianalumab employs a dual mechanism by depleting B cells and blocking the BAFF-R receptor essential to their survival.
  • Novartis will present the NEPTUNUS data at an upcoming medical meeting and submit marketing applications to global regulators.
  • The results boost the value of Novartis’ $2.9 billion MorphoSys acquisition after earlier write-downs related to its myelofibrosis candidate pelabresib.