Fingolimod Accord | European Medicines Agency (EMA)

April 20, 2025

[ad_1]

Overview

Fingolimod Accord is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.

Fingolimod Accord is a ‘generic medicine’. This means that Fingolimod Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Gilenya.

Fingolimod Accord contains the active substance fingolimod.

Fingolimod Accord can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Fingolimod Accord is available as capsules (0.5 mg). The recommended dose for adults is one capsule taken once a day by mouth, the recommended dose for children depends on body weight.

Because Fingolimod Accord decreases the heart rate and can affect the heart’s electrical activity and rhythm, the patient’s blood pressure and heart activity are checked before starting treatment and during treatment, and also if Fingolimod Accord treatment is restarted after an interruption. Details on the recommendations for monitoring patients are found in the summary of product characteristics.

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

In multiple sclerosis, the immune system (the body’s defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord.

The active substance in Fingolimod Accord, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1- phosphate receptor, which is involved in controlling the movement of these cells in the body.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Gilenya, and do not need to be repeated for Fingolimod Accord.

As for every medicine, the company provided studies on the quality of Fingolimod Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Fingolimod Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Fingolimod Accord has been shown to have comparable quality and to be bioequivalent to Gilenya. Therefore, the Agency’s view was that, as for Gilenya, the benefits of Fingolimod Accord outweigh the identified risks and it can be authorised for use in the EU.

The company that markets Fingolimod Accord must ensure that all doctors who prescribe the medicine receive an information pack containing important safety information, including a checklist of the risks with Fingolimod Accord and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Fingolimod Accord. The pack will also include a reminder card for patients or their carers with key safety information about Fingolimod Accord, and a pregnancy-specific card to remind patients that Fingolimod Accord must not be used during pregnancy and in women who can become pregnant and are not using effective contraception.

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

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

Fingolimod Accord received a marketing authorisation valid throughout the EU on 25 June 2020.

English (EN)
(143.12 KB – PDF)

First published: 03/07/2020

View

English (EN)
(430.29 KB – PDF)

First published: 03/07/2020

View

Product information

English (EN)
(844.61 KB – PDF)

First published: 03/07/2020Last updated: 11/04/2025

View

Latest procedure affecting product information:
005191/R/0011

04/04/2025

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)
(14.71 KB – PDF)

First published: 03/07/2020

View

Product details

Name of medicine: Fingolimod Accord
Active substance: fingolimod hydrochloride
International non-proprietary name (INN) or common name: fingolimod
Therapeutic area (MeSH): Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code: L04AA27

Pharmacotherapeutic group

Immunosuppressants
Selective immunosuppressants

Therapeutic indication

Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy

Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

More information on Fingolimod Mylan

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

View

[ad_2]

Source link

Overview

How is Fingolimod Accord used?

How does Fingolimod Accord work?

How has Fingolimod Accord been studied?

What are the benefits and risks of Fingolimod Accord?

Why is Fingolimod Accord authorised in the EU?

What measures are being taken to ensure the safe and effective use of Fingolimod Accord?

Other information about Fingolimod Accord

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

More information on Fingolimod Mylan

LEAVE A REPLY Cancel reply