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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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2024
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Genmab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2022
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Genmab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
Multicenter survey results show MS patients and nurses prefer the Sensoready autoinjector pen for subcutaneous self-administration of Kesimpta over other autoinjectors for their current treatment (84% vs 16%).
Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: Kesimpta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2021
Details:
CHMP opinion is based on two Phase III ASCLEPIOS studies that met the primary endpoints where Kesimpta showed a reduction of the annual relapses by over 50% versus teriflunomide and achieved more than 30% relative risk reduction of 3-month confirmed disability progression.
Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: Kesimpta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients.
Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: OMB157
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
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