Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Reports Six-Year Efficacy Data of Kesimpta® in Treatment-Naïve Relapsing MS
Details : Kesimpta (ofatumumab) is the first fully human anti-CD20 monoclonal antibody self-administered by a once-monthly injection, delivered subcutaneously in RMS.
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
April 17, 2024
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
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 ...
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
June 27, 2022
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
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 peri...
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
May 04, 2022
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
March 18, 2022
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
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 sa...
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
February 03, 2022
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab,13-Valent Pneumococcal Conjugate Vaccine,Tetanus Toxoid Vaccine
Therapeutic Area : Neurology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
October 14, 2021
Lead Product(s) : Ofatumumab,13-Valent Pneumococcal Conjugate Vaccine,Tetanus Toxoid Vaccine
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Phase IV
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ofatumumab is an anti-CD20 IgG1κ human monoclonal antibody used for treatment for chronic lymphocytic leukemia and relapsing forms of multiple sclerosis (MS).
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
July 10, 2021
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gets European and UK Licence for Kesimpta
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.
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
July 04, 2021
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
April 16, 2021
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Receives EU Approval for Kesimpta® (Ofatumumab)
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.
Product Name : Kesimpta
Product Type : Antibody
Upfront Cash : Inapplicable
March 30, 2021
Lead Product(s) : Ofatumumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Genmab
Deal Size : Inapplicable
Deal Type : Inapplicable