Novartis’ Ianalumab Achieves Phase III Success in Immune Thrombocytopenia

Novartis has reported positive results from the Phase III VAYHIT2 trial (NCT05653219) evaluating its monoclonal antibody ianalumab in patients with immune thrombocytopenia (ITP). The therapy, when combined with Promacta (eltrombopag), significantly extended the time to treatment failure (TTF) compared with Promacta and placebo, meeting its primary endpoint. It also achieved its secondary endpoint, delivering a sustained rise in platelet counts after six months, including in patients previously treated with corticosteroids.

The once-monthly regimen demonstrated a favorable safety profile, with no new safety concerns identified. Novartis plans to seek global regulatory approval in 2027, supported by data from its ongoing first-line trial, VAYHIT1.

If approved, ianalumab could reduce patient dependence on frequent hospital visits for treatments such as immunoglobulin infusions and rituximab, improving quality of life. However, it faces competition from Sanofi’s oral BTK inhibitor rilzabrutinib, expected to gain FDA approval by August 2025.

16-08-2025