Novartis Reports Positive Phase III Results for Ianalumab in ITP

Novartis has announced encouraging results from the Phase III VAYHIT2 trial evaluating ianalumab in combination with eltrombopag for patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids. The study showed that four once-monthly doses of ianalumab at 9 mg/kg significantly prolonged disease control, extending time to treatment failure (TTF) by 45% compared with placebo plus eltrombopag. Median TTF reached 13 months in the ianalumab group, versus 4.7 months in the placebo arm.

At six months, 62% of patients receiving ianalumab achieved sustained platelet count improvements, compared with 39% in the placebo group. Patients also reported greater reductions in fatigue. The higher dose met both primary and key secondary endpoints, while a lower dose improved the primary endpoint only.

Ianalumab was generally well tolerated, with no new safety concerns. Common side effects included infusion reactions and headache, while neutropenia resolved without intervention. Novartis plans to submit the data in 2027.

19-12-2025