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The FDA is expected to decide on Ianalumab for Sjögren's disease in an undisclosed window, under a BLA from Novartis.
What the FDA is deciding on Ianalumab for Sjögren's disease
The FDA is reviewing Novartis' application to approve Ianalumab (VAY736) for sjögren's disease.
A monthly injection under the skin that removes B cells and blocks the BAFF receptor. Novartis completed its US, EU, China and Japan submissions in the first quarter of 2026, and the FDA granted priority review on top of its January 2026 Breakthrough Therapy designation.
The 2 Phase 3 trials, published in the New England Journal of Medicine on October 22, 2026, showed a small but statistically significant drop in the ESSDAI disease activity score at week 48 with the monthly dose and no significant difference in symptom scores. Novartis has not disclosed a decision date. If approved, it would be the first targeted treatment for Sjögren's disease.
Who the Ianalumab decision matters to
Sjögren's syndrome is a chronic autoimmune disorder in which the immune system attacks the moisture-producing exocrine glands, primarily the salivary and lacrimal (tear) glands. The resulting sicca (dryness) symptoms are the hallmark of the disease, but Sjögren's is a systemic condition that can affect the lungs, kidneys, nervous system, joints, and blood vessels.
Patients face a 5 to 10% lifetime risk of developing B-cell non-Hodgkin lymphoma.
Prevalence: Estimated 1 to 4 million Americans (including undiagnosed); approximately 1 in 1,000 adults based on physician-diagnosed prevalence. See our full Sjögren's Syndrome page for current treatments, recruiting trials, and community resources.
How Ianalumab works
Ianalumab: fully human monoclonal antibody targeting the BAFF receptor (BAFF-R) on B cells, depleting mature B cells and blocking BAFF-mediated B-cell survival signaling that drives autoimmune gland destruction. Our full Ianalumab profile covers how it works, side effects in plain language, and its trial history.
What an approval or a rejection of Ianalumab would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Sjögren's Syndrome treatment stands today
Read our full Sjögren's Syndrome treatment summary
Sjögren's syndrome has no FDA-approved disease-modifying treatment, which means clinical trials represent a real opportunity for patients with moderate-to-severe disease who aren't adequately controlled with symptomatic therapies. Trials are testing B-cell depletion (ianalumab, which targets BAFF receptor), JAK inhibitors (deucravacitinib), T-cell co-stimulation blockers (dazodalibep), and dual BAFF/APRIL inhibitors (telitacicept).
Ask your rheumatologist whether your autoantibody profile (SSA/Ro, SSB/La) and disease activity scores make you eligible for current trials, whether your systemic symptoms (fatigue, neuropathy, joint involvement) indicate a need for immunomodulatory therapy beyond symptomatic management, and whether your lymphoma surveillance schedule is appropriate given your specific risk markers.
The Sjögren's Foundation maintains trial listings and connects patients with clinical centers running active studies.
The Sjögren's Syndrome page has every treatment and trial →Meanwhile, 45 Sjögren's Syndrome studies are open or about to open
Whatever the FDA decides here, research on Sjögren's Syndrome does not stop. Of these, 33 test a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Sjögren's Syndrome. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Sjögren's Syndrome. Turn any of these off from the link in every email.
Frequently asked questions
When will the FDA decide on Ianalumab?
Novartis has not disclosed a decision date.
Who disclosed it: Novartis. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Ianalumab being reviewed for?
Novartis submitted a BLA for Ianalumab in Sjögren's disease.
What to know: A monthly injection under the skin that removes B cells and blocks the BAFF receptor. Novartis completed its US, EU, China and Japan submissions in the first quarter of 2026, and the FDA granted priority review on top of its January 2026 Breakthrough Therapy designation. The 2 Phase 3 trials, published in the New England Journal of Medicine on October 22, 2026, showed a small but statistically significant drop in the ESSDAI disease activity score at week 48 with the monthly dose and no significant difference in symptom scores. Novartis has not disclosed a decision date. If approved, it would be the first targeted treatment for Sjögren's disease.
How it works: Fully human monoclonal antibody targeting the BAFF receptor (BAFF-R) on B cells, depleting mature B cells and blocking BAFF-mediated B-cell survival signaling that drives autoimmune gland destruction.
More: the Ianalumab drug page explains it in plain language.
Is there already an FDA-approved treatment for Sjögren's Syndrome?
Yes. Trial Friend's drug list includes 2 FDA-approved drugs for Sjögren's Syndrome.
Approved: Salagen (pilocarpine), Evoxac (cevimeline).
Also coming: Sotyktu (deucravacitinib), Telitacicept, Dazodalibep.
Check: the Sjögren's Syndrome page also searches FDA drug labels for approved treatments.
What did the Ianalumab trials show?
Phase 2 studies demonstrated improvements in the ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) and salivary gland function. The Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, published in the New England Journal of Medicine on October 22, 2026, enrolled 275 and 504 adults with active Sjögren's disease.
More: the Ianalumab drug page has the full trial history and sources.
What are the side effects of Ianalumab?
In Phase 2 trials, the most commonly reported side effects were injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because ianalumab depletes B cells, infection monitoring is important.
More: the Ianalumab drug page lists the warnings in full.
Can I get Ianalumab before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 45 Sjögren's Syndrome studies are open or about to open, 33 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Novartis directly. Registered programs are listed on ClinicalTrials.gov.
How much will Ianalumab cost?
Novartis has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Ianalumab decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Novartis Q1 2026 results, April 28, 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.