How Rhapsido’s symptomatic dermographism approval expands Novartis immunology strategy
Novartis’ Rhapsido won the first FDA label for symptomatic dermographism after a 29.3% complete response in Phase 3 RemIND.
Novartis’ Rhapsido won the first FDA label for symptomatic dermographism after a 29.3% complete response in Phase 3 RemIND.
FDA approves Novartis Rhapsido as the first treatment specifically for symptomatic dermographism after positive Phase III RemIND results.
The FDA has accepted Roche’s fenebrutinib filing under Priority Review for both relapsing and primary progressive multiple sclerosis, potentially creating a high-efficacy oral alternative across disease forms currently treated very differently.
Remibrutinib beat teriflunomide on relapse rates and every key secondary endpoint across the Phase 3 REMODEL studies, while avoiding the liver-safety signal that has complicated development of other BTK inhibitors.
Novartis says oral BTK inhibitor remibrutinib significantly reduced relapse rates and MRI lesions versus teriflunomide in both Phase 3 REMODEL trials, with no liver safety signal and global regulatory filings now planned.