Novartis (NYSE: NVS) presents remibrutinib relapse reductions in multiple sclerosis
Two large Phase 3 studies support a potential new indication, with longer-term disability outcomes requiring careful interpretation.
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Novartis presented detailed results from REMODEL 1 and REMODEL 2, which evaluated remibrutinib against Aubagio in relapsing multiple sclerosis. The studies enrolled more than 2,000 patients and reported reductions in annualised relapse rates of 35.2% and 31.2%, respectively.
The company also highlighted the liver-safety findings. An absence of a particular safety signal within these trials is encouraging, but should not be translated into a guarantee that no such risk exists.
Reported disability-progression analyses need separate scrutiny. Nominal statistical findings do not necessarily carry the same evidential weight as endpoints that pass the prespecified multiplicity-controlled testing procedure.
The results strengthen the case for regulatory submissions in multiple sclerosis and could broaden remibrutinib's commercial role beyond its existing use. For Novartis, the challenge is to establish a compelling balance of disease control, tolerability and convenience in a competitive market. The data announcement does not mean the medicine is already approved for MS.