Kesimpta | European Medicines Agency (EMA)

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Overview

Kesimpta is a medicine for treating adults with relapsing forms of multiple sclerosis (MS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms. It is used in patients with active disease, which means that they have relapses and/or signs of active inflammation on scans.

Kesimpta contains the active substance ofatumumab.

Kesimpta can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of conditions of the nervous system.

Kesimpta is available as a solution for injection in prefilled syringes or prefilled pens. Treatment starts with one injection under the skin every week for 3 weeks, followed by a week with no injection. The next injection is given a week later and then an injection is given every month. Patients can inject themselves with Kesimpta once they have been trained.

For more information about using Kesimpta, see the package leaflet or contact your doctor or pharmacist.

The active substance in Kesimpta, ofatumumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific target called CD20 on the surface of B cells (a type of white blood cell).

B cells play a key role in multiple sclerosis by attacking the protective covering (sheaths) around the nerves in the brain and spinal cord, causing inflammation and damage. By targeting B cells, Kesimpta helps to reduce their activity and thereby relieves symptoms or slows down the worsening of the disease.

Studies have shown that Kesimpta is effective at reducing the number of relapses and can also delay the worsening of symptoms.

In two main studies of 1,882 patients with relapsing forms of multiple sclerosis, the average number of relapses in a year in patients treated with Kesimpta was less than half that in patients treated with another multiple sclerosis medicine, teriflunomide (0.11 versus 0.24 relapses per year). The studies also showed that fewer patients taking Kesimpta (8%) had worsening symptoms lasting 6 months or more compared with those taking teriflunomide (12%).

The most common side effects with Kesimpta (which may affect more than 1 in 10 people) are upper respiratory tract infections (nose and throat infections), urinary tract infections (infections of the structures that carry urine), reactions at the site of injection (redness, pain, itching, and swelling) and injection-related reactions (fever, headache, muscle pain, chills and tiredness).

For the full list of side effects of Kesimpta, see the package leaflet.

Kesimpta must not be used in patients with severe active infections, severely weakened immune systems or cancer.

For the full list of restrictions, see the package leaflet.

Studies showed that Kesimpta was more effective than teriflunomide at reducing the number of relapses in patients with relapsing forms of multiple sclerosis. The medicine was also more effective at delaying the worsening of symptoms. Side effects are in line with those of other similar medicines and are considered manageable. The European Medicines Agency decided that Kesimpta’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kesimpta have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of the medicine are continuously monitored. Side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

Kesimpta received a marketing authorisation valid throughout the EU on 26 March 2021.

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First published: 16/04/2021

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First published: 16/04/2021Last updated: 29/03/2023

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Product information

English (EN)
(880.93 KB – PDF)

First published: 16/04/2021Last updated: 07/02/2025

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Latest procedure affecting product information:
T/0025

03/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(93.16 KB – PDF)

First published: 16/04/2021

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Product details

Name of medicine: Kesimpta
Active substance: Ofatumumab
International non-proprietary name (INN) or common name: ofatumumab
Therapeutic area (MeSH): Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code: L04AA52

Pharmacotherapeutic group

Immunosuppressant

Therapeutic indication

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).

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