Welcome!

Agile Computing Authors: Liz McMillan, Pat Romanski, Corey Roth, Elizabeth White, Yeshim Deniz

News Feed Item

Eisai Disagrees with German Institute for Quality and Efficiency in Health Care (IQWiG) Report on Innovative Antiepileptic Drug Fycompa® (Perampanel) for the Treatment of Partial Epilepsy

HATFIELD, England, December 18, 2012 /PRNewswire/ --

In the assessment report by the Institute for Quality and Efficiency in Health Care (IQWiG) on Fycompa® (perampanel), published today on the Federal Joint Committee (G-BA) website, the institute did not attest an additional benefit. Comments on the report and its proposed conclusion can be submitted to the G-BA up until 07 January 2013. The G-BA will decide on the additional benefit in March 2013 after reviewing comments and the discussion from an oral hearing of experts end of January. The current IQWiG assessment has no implications on the reimbursement of perampanel or doctors' ability to prescribe this new partial epilepsy treatment.

Eisai today expressed its strong disappointment with IQWiG in regards to their assessment of the additional benefit, of the new epilepsy treatment perampanel compared to a treatment defined by the G-BA. It is reported that additional benefit is unproven based on methodological considerations.[1] No statement was made regarding clinical efficacy and safety. Perampanel is the first in an entirely new class of treatment for uncontrolled partial epilepsy with a novel mechanism of action that is different from all other anti-epileptic drugs (AEDs). The company believes that, while discussing at length methodological aspects of analyses, IQWiG failed to adequately interpret the patient-relevant benefits and responsibly recognise the innovative nature of the new drug in a clinical setting with a high unmet need.

Perampanel is indicated as an adjunctive treatment for partial seizures (the most common form of epileptic seizures), with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[2] It was first launched in Europe in Germany and the UK in September 2012 and has been well received by both patients and doctors. It is the first and only licensed AED to selectively target AMPA receptors which play a critical role in causing seizures.[3] It blocks the effects of glutamate, which can trigger and maintain seizures.

"We believe we provided compelling evidence of the additional benefit of perampanel based on the advice received by the G-BA. By taking a negative view, IQWiG ignores the therapeutic value that this first-in-class new AED brings to the real-life clinical setting. There still remains a very high need for new drugs to reduce seizures in patients with refractory partial epilepsy," points out Franz Wetzel, Epilepsy Business Unit Director, Eisai Germany. "In addition, perampanel has the further benefit of convenient, once-daily dosing at bedtime and it is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch."

Nick Burgin, European Director of Market Access, Eisai added; "We are dismayed by this critical assessment of perampanel. Even while facing measures to cut costs in the current economic climate it remains important to consider the pressing needs of the patients for new, innovative medicines. Eisai will make all efforts to have available data adequately considered in order to achieve recognition of the resulting additional benefit.

An estimated 500.000 - 650.000 people with epilepsy live in Germany.[4] Epilepsy is one of the most common neurological conditions in the world.[5] The successful treatment of partial-onset seizures remains a challenge. Up to 30% of patients with partial-onset seizures do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.[6]

Perampanel was approved by the European Commission on 23 July 2012 and is currently available in the UK, Denmark, Germany, Austria and Sweden. Swissmedic, the Swiss Agency for Therapeutic Products approved perampanel for use on 17 December 2012. The FDA approved perampanel for use in the US on 22 October 2012.

The development of perampanel underscores Eisai's human health care (hhc) 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 with epilepsy and their families. Eisai is proud to currently market more epilepsy products in Europe, the Middle East, Africa and Russia (EMEA) than any other company.

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.[2]

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, neurodegenerative disorders, movement disorders, pain and psychiatric disorders.[2]

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. Efficacy end points for studies 304, 305, and 306 were pooled according to randomised treatment: placebo, perampanel 2, 4, 8 or 12mg. The full ITT (intention-to-treat) analysis set included 1,478 patients from studies 304 (n=387), 306 (n=386) and 306 (n=705).

Median reductions in partial seizure frequency were greater with perampanel 4 mg (-23·3%), 8 mg (-28·8%), and 12 mg (-27·2%) than placebo (-12·8%; p<0·01, each dose vs. placebo). Median (95% CI) differences from placebo in changes in partial seizure frequency were -12·2% (-20·1 to -4·6), -17·9% (-24·1 to -11·8), and -15·8% (-23·0 to -8·7) for perampanel 4, 8, and 12 mg, respectively.

Fifty percent responder rates were greater with perampanel 4 mg (28·5%), 8 mg (35·3%), and 12 mg (35·0%) than placebo (19·3%; p<0·05, each dose vs placebo). Median reductions in complex partial seizure frequency were greater with perampanel 4 mg (-31·2%), 8 mg (-35·6%), and 12 mg (-28·6%) than placebo (-13·9%).

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.[7] In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures.[8] 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.[9]

Perampanel was generally well tolerated; most adverse events were mild/moderate.

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.[10],[11] 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. Dossierbewertung A12-12 Version 1.0 Perampanel - Nutzenbewertung gemäß § 35a SGB V 13.12.2012

2. Fycompa. Summary of Product Characteristics. August 2012

3. Rogawski MA. Epilepsy Currents 2011;11:56-63

4. Pfäfflin, M. Epidemiologie der Epilepsien (online). 2011 URL: http//www.izepilepsie.de/home/showdoc.id.387.aid.4163.html.

5. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)

6. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342:314-9

7. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012

8. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012

9. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012

10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2012]

11. Pugliatti M, et al. Epilepsia 2007: 48(12);2224-2233

Date of preparation: December 2012

Job code: Perampanel - UK2118


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here)
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
The Jevons Paradox suggests that when technological advances increase efficiency of a resource, it results in an overall increase in consumption. Writing on the increased use of coal as a result of technological improvements, 19th-century economist William Stanley Jevons found that these improvements led to the development of new ways to utilize coal. In his session at 19th Cloud Expo, Mark Thiele, Chief Strategy Officer for Apcera, compared the Jevons Paradox to modern-day enterprise IT, examin...
DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City. ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ...
Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per...
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge...
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
Charles Araujo is an industry analyst, internationally recognized authority on the Digital Enterprise and author of The Quantum Age of IT: Why Everything You Know About IT is About to Change. As Principal Analyst with Intellyx, he writes, speaks and advises organizations on how to navigate through this time of disruption. He is also the founder of The Institute for Digital Transformation and a sought after keynote speaker. He has been a regular contributor to both InformationWeek and CIO Insight...
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
I think DevOps is now a rambunctious teenager - it's starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Recently, WebRTC has a lot of eyes from market. The use cases of WebRTC are expanding - video chat, online education, online health care etc. Not only for human-to-human communication, but also IoT use cases such as machine to human use cases can be seen recently. One of the typical use-case is remote camera monitoring. With WebRTC, people can have interoperability and flexibility for deploying monitoring service. However, the benefit of WebRTC for IoT is not only its convenience and interopera...
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
It is of utmost importance for the future success of WebRTC to ensure that interoperability is operational between web browsers and any WebRTC-compliant client. To be guaranteed as operational and effective, interoperability must be tested extensively by establishing WebRTC data and media connections between different web browsers running on different devices and operating systems. In his session at WebRTC Summit at @ThingsExpo, Dr. Alex Gouaillard, CEO and Founder of CoSMo Software, presented ...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, introduced two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a multip...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
IoT is rapidly becoming mainstream as more and more investments are made into the platforms and technology. As this movement continues to expand and gain momentum it creates a massive wall of noise that can be difficult to sift through. Unfortunately, this inevitably makes IoT less approachable for people to get started with and can hamper efforts to integrate this key technology into your own portfolio. There are so many connected products already in place today with many hundreds more on the h...
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...