Novartis updates Scemblix label; registers PV real-world study and CAD trial

Three routine Novartis regulatory and trial items posted this week.

• The FDA approved a labeling supplement for Scemblix covering oral tablets of asciminib hydrochloride at 20mg, 40mg, and 100mg strengths.¹ The filing was submission number 15, a standard-priority labeling supplement, with an approval status date of 2026-09-22.¹
• Novartis completed a non-interventional French study called "VeRavie" looking at how second-line cytoreductive treatments are used for polycythemia vera. The study aimed to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians switch treatments.² Data came from medical charts of patients who initiated a second-line cytoreductive agent for the treatment of PV and received their first dose between 1 Jan 2022 and 31 Dec 2023,² with enrollment of 237 participants.²
• Novartis began recruiting for a Phase 2b dose-finding trial of YMI024 in adults with stable coronary artery disease and elevated hsCRP. The study will test five doses of YMI024 against placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L),³ with planned enrollment of 180 participants.³ The primary outcome is change from baseline in log-transformed IL-6, evaluated using the Multiple Comparison Procedures (MCP) component of the Multiple Comparison Procedure-Modelling (MCP-Mod) methodology.³