Fampyra
Active
Substance: fampridine
Common Name: fampridine
ATC Code: N07XX07
Marketing Authorisation Holder: Biogen Idec Ltd
Active Substance: fampridine
Status: Authorised
Authorisation Date: 2011-07-20
Therapeutic Area: Multiple Sclerosis
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).
What is Fampyra
and what is it used for?
Fampyra is a
medicine 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.
It contains the
active substance fampridine.
How is Fampyra
used?
Fampyra is
available as 10 mg tablets taken without food twice a day, 12 hours apart.
After two to
four weeks, patients are evaluated and those who have not shown an improvement
should stop treatment. Treatment should also be stopped if a patient’s walking
ability worsens or if the patient does not report any benefit.
The medicine can
only be obtained with a prescription, and should be prescribed by a doctor
experienced in treating MS. For further information, see the package leaflet.
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.
What benefits of
Fampyra have been shown in studies?
Two main studies
in 540 patients with multiple sclerosis showed that Fampyra was more effective
than placebo (a dummy treatment) at improving walking speed. The patients were
treated for 9 or 14 weeks, with their waking speed measured along a 25 feet
(7.5 metres) footpath.
In one of the
studies 35% of patients taking Fampyra had higher walking speed on at least
three out of four occasions than their quickest speed before treatment compared
with 8% of patients taking placebo . In the second study the results were
similar, with 43% of patients in the Fampyra group surpassing their previous
best speed on three out of four occasions, compared with 9% in the placebo
group.
A third study in
633 patients measured improvements in walking ability over 24 weeks using a
rating scale known as the multiple sclerosis walking scale (MSWS), where patients
rated how well they were able to do various activities such as walking, running
or climbing stairs. In this study, 43% of patients taking Fampyra had at least
an 8-point improvement in their MSWS score compared with 34% of those on
placebo. (An 8-point improvement is considered clinically significant in this
scale, which ranges from 0 to 100).
What are the
risks 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 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. For the full list of restrictions, see the package
leaflet.
Why is Fampyra
approved?
The studies with
Fampyra showed that the medicine is 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. With regard to the medicine’s safety, serious side
effects with Fampyra are rare.
The European
Medicines Agency 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 was
originally given ‘conditional approval’ because there was more evidence to come
about the medicine. As the company has supplied the additional information
necessary, the authorisation has been switched from conditional to full
approval.
What measures
are being taken to ensure the safe and effective use of Fampyra?
Recommendations
and precautions to be followed by healthcare professionals and patients for the
safe and effective use of Fampyra have been included in the summary of product
characteristics and the package leaflet.
Other
information about Fampyra
The European
Commission granted a conditional marketing authorisation valid throughout the
European Union for Fampyra on 20 July 2011. This was switched to a full marketing
authorisation on 22 May 2017.
For more
information about treatment with Fampyra, read the package leaflet (also part
of the EPAR) or contact your doctor or pharmacist.
Source: European
Medicines Agency
