Swiss multinational pharmaceutical corporation Novartis AG (NYSE:NVS) announced on Tuesday that its Phase III VAYHIT2 trial of ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids met its primary endpoint.

Ianalumab, which has been granted Orphan Drug Designation from both the US Food and Drug Administration and the European Medicines Agency, was found to significantly extend the time to treatment failure versus placebo plus eltrombopag, indicating sustained safe platelet levels during and after therapy.

The study also met a key secondary endpoint, with the combination achieving a significantly higher rate of sustained platelet count improvement at six months. Safety outcomes were consistent with earlier trials, with no new safety signals identified.

Administered as four once-monthly doses, ianalumab has the potential to deliver long-term disease control and reduce reliance on continuous treatment. The drug is also under investigation in first-line ITP and warm autoimmune hemolytic anemia, with further Phase III results expected in 2026.

Data from VAYHIT2 will be presented at an upcoming medical meeting and included in planned regulatory submissions in 2027, alongside findings from the ongoing VAYHIT1 trial.