The FDA has granted Novartis Breakthrough Therapy Designation (BTD) for ianalumab, its investigational treatment for patients with Sjögren’s disease.

Remind me of the ocular connection to Sjögren’s disease.

While the chronic autoimmune disorder impacts the entire body, it can be detected during a comprehensive eye exam— with dry eye a hallmark feature.

• Other ocular-related signs can include blurry vision, burning or tinging eyes, light sensitivity (photophobia), contact lens discomfort, and blepharitis.

And it’s important to keep in mind: While there are FDA-approved medications that target managing specific symptoms associated with Sjögren’s, there’s currently no FDA-approved, disease-modifying treatment that addresses the root autoimmune causes of the disease.

Got it. Now talk more about Novartis’s asset.

Its background: The candidate was originally developed by the German biopharma company MorphoSys AG, which Novartis acquired in 2024.

As for the drug itself: Ianalumab is an investigational fully human monoclonal antibody designed to target B-cell activating factor receptor (BAFF-R), which drives autoimmune inflammation in diseases such as Sjögren’s.

• Its dual mechanism of action involves depleting B-cells and blocking BAFF-R signaling to reduce disease activity—see here for a more detailed breakdown of how this works.
  • Its mode of delivery: Via a subcutaneous injection.

And this FDA designation?

First, take note: This isn’t ianalumab’s first designation—the asset reportedly received Fast Track designation in 2016, which granted it:

• More frequent interactions with the FDA
• Rolling review for a future new drug application (NDA) submission

And now with BTD: Reserved for investigational drugs designed to treat a serious or life-threatening disease (such as Sjögren’s), this designation is intended to expedite its clinical development and future NDA review process (see here for criteria a drug must meet to qualify).

• Plus: BTD drugs are eligible for all Fast Track designations

Does BTD require clinical data as well?

Indeed, it does. The FDA mandates preliminary clinical evidence demonstrating that a drug may have a substantial improvement in at least one clinically significant endpoint over a currently available therapy for its target disease.

• See here for examples of this demonstration.

So … what has clinical data shown for ianalumab?

Findings from two identical global, multicenter, pivotal phase 3 trials—NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214)—have demonstrated promising results thus far in evaluating the candidate’s efficacy and safety among 700+ adult Sjögren's patients.

Case in point: Data presented in October 2025 determined a 300 mg monthly dose of ianalumab (versus placebo) delivered a clinically meaningful benefit, with both trials showing improvement in disease activity as well as reductions in treatment and patient burden.

Can you be more specific?

Importantly: Ianalumab was found to have a favorable safety profile with “an overall incidence of adverse events and serious adverse events comparable to placebo in both studies.”

In fact, the NEPTUNUS trials were referred to as the first phase 3 studies on Sjögren’s in which a “treatment significantly improved disease activity and demonstrated that ianalumab has the potential to provide a clinically meaningful benefit to patients.”

• See here for more from this data readout.

So! What’s next for the candidate?

With the NEPTUNUS trials expected to conclude in 2027 (per Clinical Trials), we may see more clinical findings on ianalumab.

However, in the meantime: Novartis plans to submit the candidate for global regulatory approval (which we’ll assume includes the FDA) in early 2026.

And the big-picture significance?

If approved, ianalumab would become the first targeted treatment for Sjögren’s.