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CLINICAL TRIAL RESULTS

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Choose KESIMPTA® (ofatumumab)

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection.

Warnings and Precautions

Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies....

INDICATION

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults...

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References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. Data on file. OMB157 (ofatumumab). ASCLEPIOS I final clinical study report. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022. 3. Data on file. OMB157 (ofatumumab). ASCLEPIOS II final clinical study report. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022. 4. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab vs teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. LB62. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Virtual. 5. Data on file. OMB157G (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 6. Kappos L, Cohen JA, Gold R, et al. Five-year efficacy outcomes of ofatumumab in relapsing MS patients: insights from ALITHIOS open-label extension study. EPR-097. Presented at: 9th Congress of the European Academy of Neurology; July 1-4, 2023; Budapest, Hungary. 7. Cohen JA, Hauser SL, Cross AH, et al. Five-year safety of ofatumumab in people living with relapsing multiple sclerosis. P8.2-004. Presented at: 75th American Academy of Neurology Annual Meeting; April 22-27, 2023; Boston, MA. 8. Hauser SL, Cross AH, Winthrop K, et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022;28(10):1576-1590. 9. Hauser SL, Fox E, Aungst A, et al. Long-term efficacy of ofatumumab in patients with relapsing multiple sclerosis. P5.004. Presented at 74th American Academy of Neurology Annual Meeting; April 2-7, 2022; Seattle, WA. 10. Hauser SL, Cross AH, Winthrop K, et al. Long-term safety of ofatumumab in patients with relapsing multiple sclerosis. S14.004. Presented at 74th American Academy of Neurology Annual Meeting; April 2-7, 2022; Seattle, WA. 11. Hauser SL, Bar-Or A, Cohen JA, et al; ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med. 2020;383(6):546-557. 12. Gärtner J, Hauser SL, Bar-Or A, et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naïve patients with multiple sclerosis: results from ASCLEPIOS I and II. Mult Scler. 2022;28(10):1562-1575. 13. Data on file. OMB157 (ofatumumab). Final clinical study report. Meta-analysis of ASCLEPIOS I/II. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022. 14. Data on file. 3-month confirmed disability worsening. Novartis Pharmaceuticals Corp; East Hanover, NJ. 2023.