FDA grants breakthrough status to experimental Sjögren’s drug ianalumab
Novartis plans to submit multiple applications for treatment's approval
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Ianalumab, an experimental treatment for Sjögren’s disease from Novartis, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA).
The FDA gives this designation to experimental therapies that have the potential to address unmet needs in the care of serious diseases, with the goal of speeding up the development and review of important new medicines.
“This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don’t have effective treatment options for this debilitating disease,” Angelika Jahreis, global head of Immunology Development at Novartis, said in a company press release.
The new designation comes just a few months after Novartis announced positive data from two Phase 3 clinical trials that tested ianalumab in Sjögren’s patients. The company plans to submit applications seeking approval of ianalumab to the FDA and other global regulatory authorities in the coming months. If approved, ianalumab would be the first targeted treatment for people with Sjögren’s disease, according to Novartis.
“We look forward to working with the agency through the regulatory review process, with the hope of making ianalumab available to appropriate patients as quickly as possible,” Jahreis said.
Ianalumab uses a dual mechanism of action
In Sjögren’s disease, immune cells called B-cells mistakenly produce antibodies that target the body’s own healthy tissues. According to Novartis, Sjögren’s is the second-most prevalent rheumatic autoimmune disease, affecting roughly 1 out of 400 people, approximately half of whom have not been diagnosed.
Ianalumab, also known as VAY736, is designed to simultaneously mark B-cells for destruction and block the B-cell activating factor receptor — a protein that, as its name implies, helps drive B-cell activation. By reducing the number of B-cells and their activity, the therapy ultimately aims to lower levels of disease-driving antibodies and ease disease severity. Ianalumab is given by subcutaneous (under-the-skin) injections.
The Phase 3 clinical trials NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) tested ianalumab against a placebo, on top of background treatment, in nearly 800 people with Sjögren’s disease.
Both studies met their main goal, which was to show that ianalumab was superior to a placebo in reducing disease activity, as measured by the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index.
The therapy also led to improvements in patient- and clinician-rated measures of overall health, and safety outcomes were generally comparable for patients given either ianalumab or a placebo.
