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[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces NEJM Publication of Phase III ASCLEPIOS Trials Demonstrating Superior Efficacy of Ofatumumab in Patients with Relapsing Multiple Sclerosis\n\nNovartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficac","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Receives Positive CHMP Opinion for Kesimpta\u00ae, A Self-Administered Treatment for Adult Patients with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Data Show Multiple Sclerosis Patients and Nurses Prefer Kesimpta\u00ae (ofatumumab) Sensoready\u00ae Autoinjector Pen","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Genmab","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis 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Disability Progression Independent of Relapse Activity in Newly Diagnosed Patients with RMS","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis To Present Broad Range of Portfolio Data At ECTRIMS, Reinforcing Long-Standing Commitment to People Living with Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase IV"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kesimpta\u00ae (ofatumumab) Data at ECTRIMS Highlights Preservation of Ig G Levels and Safety Experience Over Extended Exposure (~3.5 Years) in People Living with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase IV"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Peer-reviewed Safety and Tolerability Data Further Strengthens Kesimpta\u2019s (Ofatumumab) Favorable Benefit-risk Profile in Patients With Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Peer-reviewed Research Shows No Increased Risk of Serious Covid-19 Infections in Kesimpta\u00ae (Ofatumumab)-treated Adults With Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Presents New Four-year Data on Efficacy and Safety of Kesimpta\u00ae (Ofatumumab) in People Living With Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Genmab","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Novartis Extension Phase Data Show Nearly 80% of RMS Patients Treated With Kesimpta\u00ae (Ofatumumab) Had No Evidence of Disease Activity (Neda-3)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kesimpta\u00ae six-Year Efficacy Data Show Substantial Benefits in Recently Diagnosed Treatment-Na\u00efve People with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]

Find Clinical Drug Pipeline Developments & Deals for Ofatumumab

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            Details:

            Kesimpta (ofatumumab) is the first fully human anti-CD20 monoclonal antibody self-administered by a once-monthly injection, delivered subcutaneously in RMS.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 17, 2024

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            Details:

            New data from study showed that after four years nearly 8 out of 10 of people with RMS, treated continuously with Kesimpta® (ofatumumab) had no evidence of disease activity compared with 5 out of 10 of those who switched to Kesimpta at later date after teriflunomide treatment.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Genmab

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 27, 2022

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            Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension demonstrated the efficacy and safety of continuous Kesimpta® (ofatumumab) treatment and in those switched from teriflunomide, with no new safety risks identified over the treatment period.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 05, 2022

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            The overall fatal outcome (0.8%) and hospitalization rates (9.4%) due to COVID-19 in Kesimpta, a targeted, precisely dosed and delivered B-cell therapy-treated patients were lower than the rates reported in the overall MS population.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 18, 2022

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            Multiple Sclerosis Journal has published data from the ALITHIOS open-label extension study which provide a robust picture of continuous safety data for Kesimpta, showing it was well tolerated in ~2000 patients with up to 3.5 years exposure with no new safety risks identified.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 02, 2022

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            Details:

            Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in multiple sclerosis (MS).

            Lead Product(s): Ofatumumab,Tetanus Toxoid Vaccine,13-valent Pneumococcal Conjugate Vaccine

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 14, 2021

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            Details:

            Ofatumumab is an anti-CD20 IgG1κ human monoclonal antibody used for treatment for chronic lymphocytic leukemia and relapsing forms of multiple sclerosis (MS).

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2021

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            Details:

            Kesimpta reduced the risk of disability progression independent of relapse activity by up to almost 60% vs first-line teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 16, 2021

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            Details:

            Ofatumumab is a self-administered targeted B-cell depleting treatment option for adult patients living with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2021

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            Details:

            Kesimpta addresses the current unmet need for a high-efficacy disease-modifying therapy that combines powerful efficacy and favorable safety profile with the flexibility of self-administration at home via the Sensoready autoinjector pen.

            Lead Product(s): Ofatumumab

            Therapeutic Area: Neurology Product Name: Kesimpta

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Genmab

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2021

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