European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
No Result
View All Result
Home < INDUSTRIES Health

Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis

by Marie Weil
March 31, 2021
A A
Share on LinkedinShare on Twitter
  • There are more than 1 million people living with multiple sclerosis (MS) in Europe1, Kesimpta® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that combines powerful efficacy and favorable safety profile with the flexibility of self-administration at home via the Sensoready® autoinjector pen2,3
  • Approval based on two Phase III ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction of annual relapses by over 50% versus teriflunomide, a first-line treatment in MS, and achieved more than 30% relative risk reduction of 3-month confirmed disability progression2
  • Kesimpta may halt new disease activity in relapsing forms of MS (RMS) patients, as shown in post hoc analysis, where nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity (NEDA-3) in their second year of treatment4
  • EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan

Basel, March 30, 2021 — Novartis announced today that the European Commission has approved Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide, a first-line treatment in MS2. Kesimpta is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready® autoinjector pen and can be a first-choice treatment option for patients with RMS3.

“With more than 1 million people living with MS – an incurable condition so far – in Europe, it is encouraging to see that research continues to develop more treatments.  We welcome the approval from the European Medicines Agency that gives another treatment option for people living with RMS”, said Pedro Carrascal, President of the European Multiple Sclerosis Platform (EMSP).

“Slowing the worsening of disability is one of the main goals when managing RMS and evidence shows that early initiation of a high-efficacy treatment can improve long-term outcomes. Additionally, as RMS progresses, it can substantially increase overall healthcare costs as a result of increased disability,” said Haseeb Ahmad, Global Head of Value & Access, Novartis Pharmaceuticals. “Kesimpta’s powerful efficacy and favorable safety profile has the potential to become a first-choice treatment to help improve the quality of life of people living with MS, as well as having broader value in potentially reducing medical costs associated with infusion therapies. Kesimpta is a testament to our commitment to reimagine medicine and we remain dedicated to helping to improve the lives of people living with this disease.”

Tags: < Market

Related Industries

Health

Supporting the frontlines of Irish healthcare with AWS InCommunities

March 24, 2023
Health

Interview with Mr. Sébastien Huron, CEO, Virbac group

March 6, 2023
Health

Bayer driving innovation in radiology with new research across the portfolio presented at ECR

February 23, 2023
Health

Philips recognized as top innovator for 10th consecutive year

February 17, 2023
Health

Bayer completes acquisition of Blackford Analysis Ltd.

February 14, 2023
Health

Sandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolio

January 25, 2023
default

Voith Hydro opens new center of competence for generator components

March 8, 2023

...

Danish Carlsberg brewery saves 1 billion litres of water with new technology

March 23, 2023

...

A new dawn for the magnificent Grand Dame of La Croisette as Carlton Cannes, A Regent Hotel is poised to return

March 11, 2023

...

Stellantis and Crédit Agricole Consumer Finance Joint Venture Plans to Acquire Activities of ALD in Portugal and LeasePlan in Luxembourg

March 23, 2023

...

Allianz to invest in 960MW offshore wind farm He Dreiht in the German North Sea

March 24, 2023

...

ELC Partners with boom! to Empower Women in Supply Chain in the UK and Worldwide

March 7, 2023

...

Xiaomi Begins Product Carbon Footprint Assessment and Champions Sustainable Living Awareness

February 27, 2023

...

TotalEnergies Partners with Alimentation Couche-Tard in Belgium and Luxembourg and Sells its Networks in Germany and the Netherlands

March 17, 2023

...

Amazon pays millions of euros in corporate tax across Europe

March 8, 2023

...

Supporting the frontlines of Irish healthcare with AWS InCommunities

March 24, 2023

...

Asia Pacific Business Asia Pacific Business Asia Pacific Business

EUROPEAN BUSINESS is a premier source of corporate news, business information and insights across broad spectrum of industries in Europe and worldwide.  We are one of the members of the Business World Network.

RESOURCES

  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

CONTACT US

EDITORIAL:     editor # european-biz.com

PARTNERSHIP:     partnership # european-biz.com

HUMAN RESOURCE:     hr # european-biz.com

* (replace # with @)

  • Official Site

Copyright © EUROPEAN-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © EUROPEAN-BIZ.COM All rights reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist