Fampyra

fampridine

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This is a summary of the European public assessment report (EPAR) for Fampyra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fampyra.

What is Fampyra?

Fampyra is a medicine that contains the active substance fampridine. It is available as prolonged-release tablets (10 mg).

What is Fampyra used for?

Fampyra is used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.

MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.

The medicine can only be obtained with a prescription.

How is Fampyra used?

Treatment with Fampyra should be prescribed and supervised by a doctor experienced in MS. The recommended dose is one tablet taken by mouth, twice a day, 12 hours apart. The tablets should be taken without food.

Patients should be evaluated after two weeks and treatment should be stopped for those who have not shown an improvement. Treatment should also be stopped if a patient’s walking ability worsens or if the patient does not report any benefit.

How does Fampyra work?

For the body’s muscles to contract, electrical impulses are transmitted along the nerves to the muscles. In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.

The active substance in Fampyra, fampridine, is a potassium-channel blocker. It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells. This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.

How has Fampyra been studied?

The effects of Fampyra were first tested in experimental models before being studied in humans. The company also used data from the scientific literature.

Two main studies were performed comparing Fampyra with placebo (a dummy treatment) in 540 patients with multiple sclerosis. The patients were treated for nine or 14 weeks. The main measure of effectiveness was based on improvements in walking speed along a path of 25 feet (about 7.5 metres). Patients were considered to have responded to treatment if, on at least three out of four occasions, their walking speed was faster than their highest speed before treatment.

What benefit has Fampyra shown during the studies?

Fampyra was effective in improving walking speeds. In one of the main studies, around 35% of patients taking Fampyra responded to treatment compared with 8% of patients taking placebo. In the second study the results were similar with 43% of patients in the Fampyra group responding to treatment compared with 9% in the placebo group.

What is the risk associated with Fampyra?

The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness). The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection. For the full list of all side effects reported with Fampyra, see the package leaflet.

Fampyra should not be used in people who may be hypersensitive (allergic) to fampridine or any of the other ingredients. It must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2’ such as cimetidine. It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.

Why has Fampyra been approved?

The CHMP considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients. The Committee noted that no other medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare. The CHMP therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.

Fampyra has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular on the medicine’s long-term effects on other aspects of walking ability. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Fampyra?

The company that makes Fampyra will carry out a long term study on the effectiveness and safety of Fampyra. The study will look at the effects of Fampyra on other aspects of walking ability besides walking speed and will further investigate ways for the earlier identification of patients who respond to Fampyra earlier in order to guide further treatment.

Other information about Fampyra

The European Commission granted a marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.

For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Fampyra : EPAR - Summary for the public BG = bălgarski 2011-08-04  
Fampyra : EPAR - Summary for the public ES = español 2011-08-04  
Fampyra : EPAR - Summary for the public CS = čeština 2011-08-04  
Fampyra : EPAR - Summary for the public DA = dansk 2011-08-04  
Fampyra : EPAR - Summary for the public DE = Deutsch 2011-08-04  
Fampyra : EPAR - Summary for the public ET = eesti keel 2011-08-04  
Fampyra : EPAR - Summary for the public EL = elliniká 2011-08-04  
Fampyra : EPAR - Summary for the public EN = English 2011-08-04  
Fampyra : EPAR - Summary for the public FR = français 2011-08-04  
Fampyra : EPAR - Summary for the public IT = italiano 2011-08-04  
Fampyra : EPAR - Summary for the public LV = latviešu valoda 2011-08-04  
Fampyra : EPAR - Summary for the public LT = lietuvių kalba 2011-08-04  
Fampyra : EPAR - Summary for the public HU = magyar 2011-08-04  
Fampyra : EPAR - Summary for the public MT = Malti 2011-08-04  
Fampyra : EPAR - Summary for the public NL = Nederlands 2011-08-04  
Fampyra : EPAR - Summary for the public PL = polski 2011-08-04  
Fampyra : EPAR - Summary for the public PT = português 2011-08-04  
Fampyra : EPAR - Summary for the public RO = română 2011-08-04  
Fampyra : EPAR - Summary for the public SK = slovenčina 2011-08-04  
Fampyra : EPAR - Summary for the public SL = slovenščina 2011-08-04  
Fampyra : EPAR - Summary for the public FI = suomi 2011-08-04  
Fampyra : EPAR - Summary for the public SV = svenska 2011-08-04  

This EPAR was last updated on 04/08/2016 .

Authorisation details

Product details

Product details for Fampyra
NameFampyra
Agency product numberEMEA/H/C/002097
Active substance

fampridine

International non-proprietary name (INN) or common name

fampridine

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code N07XX07
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Fampyra
Marketing-authorisation holder

Biogen Idec Ltd
 

Revision9
Date of issue of marketing authorisation valid throughout the European Union20/07/2011

Contact address:

Biogen Idec Ltd
Innovation House
70 Norden Road
Maidenhead
Berkshire SL6 4AY
United Kingdom

Product information

Product information

21/07/2016  Fampyra -EMEA/H/C/002097 -N/0035

Name Language First published Last updated
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04
Fampyra : EPAR - Product Information SV = svenska 2011-08-04 2016-08-04

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27
Fampyra : EPAR - All Authorised presentations SV = svenska 2011-08-04 2012-03-27

Pharmacotherapeutic group

Other nervous-system drugs

Therapeutic indication

Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fampyra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-03-27 2016-08-04

Initial marketing-authorisation documents

Name Language First published Last updated
Fampyra : EPAR - Public assessment report SV = svenska 2011-08-04  
CHMP summary of positive opinion for Fampyra SV = svenska 2011-05-20  

Authorised

This medicine is approved for use in the European Union

More information on Fampyra