Scottish Medicines Consortium Approves Fycompa® (Perampanel) - Once
Daily Anti-Epileptic Treatment
HATFIELD, England, December 10, 2012 /PRNewswire/ --
Fycompa (perampanel), a treatment for partial epilepsy, is now
approved for use in Scotland after
a decision by The Scottish Medicines Consortium
(SMC).[1] It is approved for use as a second-line
adjunctive treatment in patients with refractory partial-onset
epilepsy.[1]
Almost 54,000 people in Scotland[2] have epilepsy, one of
the most common neurological diseases. The number of people
affected by the condition has been on the increase in Scotland, which saw nearly a 40% increase in
six years signifying a critical need for effective treatments for
managing the condition.[2] The SMC
approval for perampanel is the first health technology appraisal
(HTA) globally.
"This approval from the SMC is a positive step in the management
of people with epilepsy in Scotland. Uncontrolled seizures have a severe
impact on everyday function and quality of life and so we look
forward to the possibility of being able to offer our epilepsy
patients a new treatment option," comments Professor Martin Brodie, Professor of Medicine and
Clinical Pharmacology at the University of
Glasgow and Director of the Epilepsy Unit at the city's
Western Infirmary.
The data supports the use of perampanel as a new therapeutic
option for this hard-to-treat patient population. The successful
treatment of partial-onset seizures (the most common form of
epilepsy) remains a significant challenge in some patients and the
incidence of uncontrolled partial epilepsy remains high, despite
many existing anti-epileptic drugs (AEDs); between 20 - 40% of
patients with epilepsy have remained poorly controlled despite
these treatments.[3] Fycompa is licensed as an
adjunctive treatment for partial-onset seizures with or without
secondarily generalised seizures in patients with epilepsy aged 12
years and older.[4]
Nick Burgin, Director Market
Access, Eisai EMEA & Russia
explained: "We are delighted that SMC has approved perampanel for
partial epilepsy - this is the first health technology approval
(HTA) in Europe and demonstrates
the SMC's commitment to giving patients access to innovative
medicines - encouraging better patient outcomes. We hope to see
other HTA bodies following their lead and approving perampanel
across Europe."
Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only
licensed AED in Europe with a mode
of action that selectively targets AMPA receptors, which are
thought to play a central role in seizure generation and
spread.[5] This first in class
treatment selectively targets the transmission of seizures by
blocking the effects of glutamate, which can trigger and maintain
seizures. In addition, perampanel has the added benefit of
convenient, once-daily dosing taken at bedtime,[6] and
it is the only third generation epilepsy treatment approved for
adolescents which can lead to earlier seizure control in younger
patients.
The European Commission's (EC) Marketing Authorisation Approval
of perampanel was based on three global pivotal Phase III studies
with 1,480 subjects. These randomised, double-blind,
placebo-controlled, and dose-escalated studies showed
consistent results in the efficacyand tolerability of perampanel as
an adjunctive therapy in patients with partial-onset seizures (with
or without secondary
generalisations).[7],[8],[9]
The most commonly reported adverse events were dizziness,
headaches, somnolence, irritability, fatigue, falls, and
ataxia.[7],[8],[9]
The development of perampanel underscores Eisai's human
health care mission, the company's commitment to innovative
solutions in disease prevention, cure and care for the health and
well being of people worldwide. Eisai is committed to the
therapeutic area of epilepsy and addressing the unmet medical needs
of patients and their families.
Notes to Editors
About Perampanel
Perampanel is licensed in Europe Union as an adjunctive
treatment for people aged 12 years and older with partial-onset
seizures, with or without secondarily generalised seizures.
Perampanel is a highly selective, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type
glutamate receptor antagonist that has demonstrated seizure
reduction in Phase II and III studies. AMPA receptors, widely
present in almost all excitatory neurons, transmit signals
stimulated by the excitatory neurotransmitter glutamate within the
brain and are believed to play a role in central nervous system
diseases characterised by excess neuroexcitatory signaling
including epilepsy .
Further information for healthcare professionals can be found at
http://www.fycompa.eu
About the Perampanel pooled data (Study
306, 305 and 304)
The pooled Phase III data analysed the efficacy of once-daily
perampanel in reducing partial-onset seizures, the most common form
of epilepsy, and its effectiveness and flexibility of use as add-on
therapy. Perampanel is licensed for the adjunctive treatment of
partial-onset seizures with or without secondarily generalized
seizures in patients with epilepsy. The Scottish Medicines
Consortium (SMC) considers perampanel when positioned for use as a
second-line adjunctive treatment in patients with refractory
partial onset epilepsy i.e. patients who have previously received
monotherapy and are not seizure free after at least one other
adjunctive therapy.
Results from two separate analyses of pooled data from the
perampanel pivotal Phase III clinical trial programme endorse the
efficacy and safety of the new AED at clinically relevant
doses.[10] In addition, the results show that perampanel
decreased the frequency of both complex partial seizures and
secondarily generalised seizures.[11] In a third
analysis of the pooled trial data, patients with uncontrolled
partial-onset seizures taking any of the five most commonly-used
AEDs with perampanel as an add-on therapy experienced a reduction
in their seizure frequency. Patients generally received additional
benefit from increased doses of perampanel.[12]
The clinical development plan for perampanel consisted of three
global Phase III studies (studies 306, 305 and 304). The key goal
of Study 306[7] was to identify the
minimal effective dose and included four treatment arms (placebo,
2mg, 4mg, and 8mg). Study 304[8] and
Study 305[9] included three arms
(placebo, 8mg, and 12mg) and were to evaluate a more extended dose
range. The studies were similar in design: global, randomised,
double-blind, placebo-controlled, dose-escalation, parallel-group
studies. The primary and secondary endpoints were the same in all
the studies: percentage change in seizure frequency, 50% responder
rate, percentage reduction of complex partial plus secondarily
generalised seizures, and evaluation for dose response. The primary
endpoint for the EMA is 50% responder rate and for the FDA is
median percent change in seizure frequency.
About Epilepsy
Epilepsy is one of the most common neurological conditions in
the world, affecting approximately eight in 1,000 people in
Europe, and an estimated 50
million people with the condition
worldwide.[13],[14] Epilepsy is a
chronic disorder of the brain that affects people of all ages. It
is characterised by abnormal discharges of neuronal activity
causing seizures. Seizures can vary in severity, from brief lapses
of attention or jerking of muscles, to severe and prolonged
convulsions. Depending on the seizure type, seizures may be limited
to one part of the body, or may involve the whole body. Seizures
can also vary in frequency from less than one per year, to several
per day. Epilepsy has many possible causes but often the cause is
unknown.
About Eisai Europe in Epilepsy
Eisai is committed to developing and delivering highly
beneficial new treatments to help improve the lives of people with
epilepsy. The development of AEDs is a major strategic area for
Eisai in Europe, the Middle East, Africa and Russia (EMEA).
In the EMEA region, Eisai currently has four marketed treatments
including:
- Zonegran® (zonisamide) as monotherapy and adjunctive
therapy in adult patients with partial-onset seizures, with or
without secondary generalisation. (Zonegran is under license from
the originator Dainippon Sumitomo Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive
therapy in adult patients with partial-onset seizures, with or
without secondary generalisation. (Zebinix is under license from
BIAL)
- Inovelon® (rufinamide) for the adjunctive treatment
of seizures associated with Lennox-Gastaut Syndrome in patients
>4 years
- Fycompa® (perampanel) for use as an adjunctive
treatment for partial onset seizures, with or without secondarily
generalised seizures, in patients with epilepsy aged 12 years and
older
About Eisai
Eisai recently expanded their UK Hatfield commercial, research
and manufacturing facility which now supports the company's growing
EMEA business.
Eisai concentrates its R&D activities in three key
areas:
- Neuroscience, including: Alzheimer's disease, epilepsy, pain
and weight loss
- Oncology including: anticancer therapies; tumour regression,
tumour suppression, antibodies, etc.
- Vascular/Immunological reaction including: thrombocytopenia,
rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe
and its domestic home market of Japan, Eisai employs more than 11,000 people
worldwide. In Europe, Eisai
undertakes sales and marketing operations in over 20 markets,
including the United Kingdom,
France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech
Republic, Slovakia,
the Netherlands, Belgium, Luxembourg, the Middle East and Russia. For further information please visit
our web site http://www.eisai.com.
References
1. SMC website http://www.scottishmedicines.org.uk
2.
http://www.bbc.co.uk/news/uk-scotland-glasgow-west-15888339
3. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia
2007: 48 (Suppl1) 3-7
4. Fycompa. Summary of Product Characteristics. August 2012
5. Rogawski MA. Epilepsy Currents 2011;11:56-63
6. Fycompa Summary of Product Characteristics. 2012
7. Krauss G L et al. Neurology 2012; 78: 1408-1415.
8. French JA. Neurology 2012;79:589-596.
9. French J A et al.Epilepsia 2012. Article in press
10. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract
presented at ECE 2012
11. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented
at ECE 2012
12. Trinka E, Straub H, Squillacote D et al. Abstract presented
at ECE 2012
13. Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
[Accessed August 2012].
14. Pugliatti M, et al. Epilepsia 2007: 48(12);2224-2233.
Date of preparation: December
2012
Job Code: Perampanel-UK2116