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- Novartis AG NVS announced new long-term data from the ALITHIOS open-label extension study of Kesimpta (ofatumumab) for relapsing multiple sclerosis patients.
- Data showed that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability worsening events and low brain volume change versus those who started on teriflunomide and were later switched to Kesimpta.
- In people with RMS who continued in the ALITHIOS study for up to five years, earlier treatment with Kesimpta was associated with fewer confirmed disability worsening (CDW) events, including progression independent of relapse activity and relapse-associated worsening, versus those who switched later from teriflunomide.
- More than 80% of patients remained free of six-month CDW over the same five-year period.
- Brain volume change remained low (less than 1.5% loss) with Kesimpta treatment over five years. Overall, patients initially randomized to Kesimpta had lower levels of brain volume loss at year five than those initially randomized to teriflunomide.
- The annual rate of brain volume change (ABVC) in the core Phase 3 trials for continuous Kesimpta was -0.34%/year, and in the switch group, -0.42%/year (P=0.115).
- In the extension, ABVC in the Kesimpta group was -0.27%/year, and in the switch group, -0.28%/year (P=0.666).
- The separate analysis of the ALITHIOS extension data showed consistent safety results of Kesimpta for people with RMS following up to five years of treatment.
- The overall rates of adverse events (AEs) and serious AEs were consistent with the core Phase 3 trials.
- The overall rate of serious infections also remained stable, with no increased risk over five years.
- Price Action: NVS shares are up 0.08% at $98.10 during the premarket session on the last check Thursday.
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