Novartis reports remibrutinib success, suspends rap-cel studies
Novartis said two Phase 3 REMODEL studies showed remibrutinib was superior to teriflunomide at lowering relapse rates and slowed disability progression in relapsing multiple sclerosis, with no hepatic safety signals observed; the company plans worldwide regulatory submissions and will present full data in Toronto. Separately, Novartis suspended eight rap-cel CAR-T studies on Aug. 24 after three deaths from severe immune reactions, while oncology trials continue. Novartis is investigating the events with independent safety monitors and updating regulators, producing simultaneous clinical upside for an oral MS candidate and serious safety scrutiny for its CAR-T autoimmune program.
Novartis will seek global approval for remibrutinib after positive Phase 3 results
Context
Novartis reported positive Phase 3 remibrutinib results against an existing oral MS drug. The company also paused rap-cel autoimmune trials after three fatal immune reactions. Next, Novartis will file remibrutinib globally and investigate…
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