Novartis Halts Ianalumab Development for Hidradenitis Suppurativa, Focuses on Other Indications

Novartis, the Swiss pharmaceutical giant, has announced the discontinuation of its ianalumab program for hidradenitis suppurativa following disappointing results in a phase 2 clinical trial. The company, however, remains optimistic about the drug's potential in other indications, particularly Sjögren's disease.

Ianalumab Falls Short in Dermatology Study

Novartis revealed in its second-quarter earnings results that ianalumab, a dual mechanism B cell-depleting antibody targeting the BAFF-R protein, failed to meet "predefined efficacy thresholds" in a phase 2 study for hidradenitis suppurativa. This painful skin condition causes lumps to form in areas where skin rubs together.

Despite showing efficacy versus placebo, the results did not meet Novartis' target criteria, leading to the decision to halt further development in this indication. The company stated, "No new safety signals were observed," emphasizing that the drug's safety profile remains intact.

Continued Development in Other Indications

While the setback in hidradenitis suppurativa is significant, Novartis continues to pursue ianalumab's development in other B-cell driven diseases. Most notably, the company is preparing for a potential approval application next year in Sjögren's disease, an immune disorder characterized by dry eyes and mouth.

Two phase 3 trials for ianalumab in Sjögren's disease are scheduled to report results in the second half of this year. Additionally, a late-stage study in second-line immune thrombocytopenia is ongoing.

Shreeram Aradhye, M.D., Novartis' chief medical officer and head of development, previously highlighted ianalumab's promise in Sjögren's disease, noting that it had "shown meaningful differences in patients with this very difficult to treat disease" in a phase 2 trial.

Alternative Pipeline Options

Despite the setback with ianalumab in hidradenitis suppurativa, Novartis maintains a robust pipeline for the condition. The company is currently developing remibrutinib, a BTK inhibitor, which demonstrated reduced disease activity in a phase 2b trial last year. Two phase 3 trials for remibrutinib in hidradenitis suppurativa are underway, with results expected in 2028.

This strategic pivot underscores Novartis' commitment to addressing unmet needs in dermatology while optimizing its development pipeline based on clinical outcomes.