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Novartis AG (NYSE:NVS) released data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed relapsing multiple sclerosis.
Recently diagnosed is defined as untreated patients starting treatment within three years of initial diagnosis.
These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening (CDW) events, respectively, versus those who switched from Sanofi SA’s (NASDAQ:SNY) Aubagio (teriflunomide) to Kesimpta.
In the first analysis, the low annualized relapse rate (ARR) experienced by recently diagnosed treatment-naïve RMS patients was further reduced in the ALITHIOS open-label extension study, from 0.104 to 0.050 (52.0% reduction), corresponding to an adjusted ARR of one relapse per 20 years.
The second analysis looked at the overall ALITHIOS population:
Treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified.
In fiscal year 2023, Kesimpta’s sales almost doubled to $2.2 billion.
Price Action: NVS shares are up 0.15% at $93.34 on the last check Wednesday.
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