CSU is a common and distressing skin condition that causes red, raised, itchy, and sometimes painful hives or wheals (raised rash or patches) on the skin with no known obvious trigger.

In Phase 3 studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant early symptom improvement, sustained up to Week 52, in patients with CSU who remained symptomatic despite second-generation H1-antihistamine use.

New long-term Phase III REMIX-1 and REMIX-2 data assessed at Week 52 show:

Remibrutinib was well-tolerated and demonstrated a favorable and consistent safety profile up to 52 weeks, including balanced liver function tests versus placebo.

Novartis will submit remibrutinib for approval in CSU to global health authorities starting in H2 2024.

Concurrently, Novartis presented Phase 3 ASC4FIRST trial results at the 2024 American Society of Clinical Oncology meeting.

Scemblix (asciminib) demonstrated superior major molecular response (MMR) rates at week 48 compared to investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) imatinib, nilotinib, dasatinib and bosutinib, and compared to imatinib alone in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Scemblix demonstrated MMR rates at week 48 vs. investigator-selected SoC TKIs (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%). 

Scemblix also showed a numerical improvement in MMR at week 48 vs. second-generation TKIs (nilotinib, dasatinib, and bosutinib).

Additionally, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events and treatment discontinuations.

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Image generated using artificial intelligence via Midjourney.