Primary immune thrombocytopenia (ITP)
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Novartis' Investigational Drug Reports Longer Disease Control In Patients With Rare Blood Disorder
Benzingaยท 2025-12-09 19:32
Core Insights - Novartis AG announced results from the VAYHIT2 Phase 3 trial of ianalumab plus eltrombopag for patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids [1][5] Group 1: Trial Results - Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, with a median time to treatment failure of 13.0 months compared to 4.7 months for placebo plus eltrombopag [2] - The sustained platelet count improvement rate at six months was significantly higher for ianalumab plus eltrombopag at 62% versus 39% for placebo plus eltrombopag [4] - Fatigue improvement was also noted, with a mean reduction of 7.7 points for ianalumab plus eltrombopag compared to 3.6 points for placebo plus eltrombopag [4] Group 2: Additional Insights - The estimated probability of being free from treatment failure at 12 months was 54% in the 9-mg group, 51% in the 3-mg group, and 30% in the placebo group [5] - Ianalumab is under investigation for other B-cell-driven autoimmune diseases, with ongoing Phase 3 trials in first-line ITP and in second and later lines of warm autoimmune hemolytic anemia, with results expected in 2026 [5] - Novartis stock increased by 1.46% to $132.07 at the time of publication [5]