|By PR Newswire||
|January 15, 2014 07:02 PM EST||
HATFIELD, England, January 16, 2014 /PRNewswire/ --
Fycompa® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), launches today in Spain. The new therapy is indicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.
Epilepsy is one of the most common neurological conditions in the world. Around 400,000 people in Spain live with the condition.
"Almost a third of people with partial epilepsy continue to experience seizures despite the treatment options currently available," commented Dr. José Serratosa, an Epileptologist at the Epilepsy Unit of the Fundación Jiménez Díaz University Hospital, Madrid. "New treatment options such as this are a welcome addition to doctors' epilepsy treatment armamentarium."
Perampanel's reimbursement approval in Spain is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307). The three global pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.,, The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.,, Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.
Dr. Javier Sánchez, Medical Manager, Eisai Spain, commented: "We're pleased to announce the launch of perampanel in Spain. As an emerging leader in the field of epilepsy, Eisai is committed to developing innovative therapies to meet the unmet needs of people with epilepsy who need alternative treatment options to help them achieve seizure control."
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012.
The launch of perampanel in Spain 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 wellbeing of people worldwide.
Notes to Editors
Fycompa is indicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
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 signalling including epilepsy.
For more information please visit: 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.
50% 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. In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures. 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.
Perampanel was generally well tolerated; most adverse events were mild/moderate.
The 307 study (n=1,218) was designed to evaluate safety, tolerability, and seizure outcome data during long-term treatment with once-daily adjunctive perampanel (up to 12 mg/day) in people with refractory partial onset seizures. It was an open-label extension (OLE) study for people completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306).
The study consisted of two phases: an open-label treatment phase (including a 16-week conversion period and a planned 256-week maintenance period) and a 4-week follow-up phase. People were blindly titrated during the Conversion Period to their individual maximum tolerated dose (maximum 12 mg/day). Adverse events (AEs) were monitored throughout the study and seizure frequency recorded. The interim data cut-off date for analyses was 1 December 1 2010.
At the interim cut-off date, 1186 patients were in the safety analysis set; 1089 (91.8%) patients had >16 weeks' exposure to perampanel, 580 (48.9%) patients had >1 year of exposure, and 19 (1.6%) patients had >2 years' exposure. At the interim analysis, 840 (70.8%) patients remained on perampanel treatment. The large majority of patients (n=1084 [91%]) were titrated to 10 mg or 12 mg/day. Median (range) duration of exposure was 51.4 (1.1-128.1) weeks.
In the ITT analysis set (n=1207), the frequency of all seizures decreased over the first 26 weeks of perampanel treatment in patients with at least 26 weeks' exposure to perampanel (n=1006 [83.3%]); this reduction was maintained in patients with at least one year of exposure (n=588 [48.7%]). The overall median percent changes in seizure frequency in patients included in each 13-week interval of perampanel treatment were -39.2% for weeks 13-26 (n=1114), -46.5% for Weeks 40-52 (n=731), and 58.1% for Weeks 92-104 (n=59). Overall responder rates in patients included in each 13-week interval of perampanel treatment were 41.4% for Weeks 13-26 (n=1114), 46.9% for Weeks 40-52 (n=731) and 62.7% for weeks 92-104 n=59). During the blinded conversion period, the reduction in seizure frequency in patients previously randomised to placebo (-42.4%, n=369) was similar to that in patients previously randomised to perampanel (-41.5%, n=817).
Treatment-emergent AEs were reported in 87.4% of patients. The most frequent were dizziness (43.9%), somnolence (20.2%), headache (16.7%), and fatigue (12.1%). Serious AEs were reported in 13.2% of patients.
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 worldwide., 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 EMEA 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, Russia and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without generalisation, in adults, adolescents and children aged six years and above. (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 (Rufinamide was originally developed by Novartis)
- 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
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).
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 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
1. SPC Fycompa (updated November 2012). Available at: http://www.medicines.org.uk/emc/medicine/26951/ [Accessed September 2013]
2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56-63
3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed September 2013)
4. García-Ramos R, et al. FEEN: Informe sociosanitario FEEN sobre la epilepsia en España. Neurología. 2011;26:548-55. http://www.elsevier.es/sites/default/files/elsevier/eop/S2173-5808(11)00042-3.pdf (Accessed September 2013)
5. Krauss GM. et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012; 78:1408-1415
6. French JA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012;79:589-596
7. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2012:1-9
8. Krauss GL et al. Perampanel, a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from phase III, extension study 307. Epilepsia, 2013;54(1):126-34.
9. Ben-Menachem E,Krauss GL, Noachtar S et al. Abstract presented at ECE 2012
10. Steinhoff BJ, Gauffin H, McKee P et al. Abstract presented at ECE 2012
11. Trinka E, Straub H, Squillacote D et al. Abstract presented at ECE 2012
12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed September 2013]. 13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.
13. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224-2233.
Date of preparation: January 2014
Job code: Perampanel-UK2142
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Nov. 30, 2015 01:45 PM EST Reads: 426
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 30, 2015 01:45 PM EST Reads: 432
Most of the IoT Gateway scenarios involve collecting data from machines/processing and pushing data upstream to cloud for further analytics. The gateway hardware varies from Raspberry Pi to Industrial PCs. The document states the process of allowing deploying polyglot data pipelining software with the clear notion of supporting immutability. In his session at @ThingsExpo, Shashank Jain, a development architect for SAP Labs, discussed the objective, which is to automate the IoT deployment proces...
Nov. 30, 2015 01:12 PM EST
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 30, 2015 01:00 PM EST Reads: 537
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 30, 2015 12:45 PM EST Reads: 342
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 30, 2015 12:45 PM EST Reads: 288
Countless business models have spawned from the IaaS industry – resell Web hosting, blogs, public cloud, and on and on. With the overwhelming amount of tools available to us, it's sometimes easy to overlook that many of them are just new skins of resources we've had for a long time. In his general session at 17th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, an IBM Company, broke down what we have to work with, discussed the benefits and pitfalls and how we can best use them ...
Nov. 30, 2015 11:45 AM EST
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
Nov. 30, 2015 11:00 AM EST Reads: 217
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 30, 2015 10:45 AM EST Reads: 462
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 30, 2015 10:30 AM EST Reads: 353
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Nov. 30, 2015 10:00 AM EST Reads: 290
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 30, 2015 09:00 AM EST Reads: 506
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Nov. 30, 2015 08:00 AM EST Reads: 565
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
Nov. 30, 2015 07:00 AM EST Reads: 468
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 30, 2015 07:00 AM EST Reads: 382