FDA Grants Breakthrough Designation to Ianalumab for Sjögren’s Disease

January 30, 2026 Dr. Michael Lee – Health Editor Health

Here’s a breakdown of the key information from the article:

what happened?

* The FDA granted breakthrough therapy designation to ianalumab (novartis) for the treatment of Sjögren’s disease. This is a significant step towards potential approval, as it expedites the growth and review process.

Why is this significant?

* Sjögren’s disease currently has limited effective treatment options.
* The breakthrough designation indicates ianalumab has shown potential to substantially improve the standard of care.
* It allows for more intensive FDA guidance and faster review.

What data supports this designation?

* Positive results from multiple studies, including the Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials.
* These trials showed ianalumab led to improvements in disease activity and reduced patient burden compared to placebo.
* The drug also demonstrated a favorable safety profile, with adverse events comparable to placebo.

Other relevant information:

* Ianalumab previously received fast track designation in 2016.
* Nipocalimab (Johnson & Johnson) is another drug that has received both fast track and breakthrough therapy designations for Sjögren’s disease.
* Angelika Jahreis (Novartis) expressed hope for fast regulatory review and availability to patients.