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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/430040/2011

EMEA/H/C/002097

EPAR summary for the public

Fampyra

fampridine

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.

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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

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 20.07.2011.

The full EPAR for Fampyra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2011.

Fampyra

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