Exelon Patch Receives European Union Approval, The First Skin Patch Therapy To Treat Alzheimer’s Disease
The European Commission hang against agreed Exelon patch (rivastigmine transdermal patch), an ahead of its time course to deliver this significant drug to patients anguish from calm fluff to relatively exacting Alzheimer’s microorganism.
Exelon patch be the opening and simply transdermal attention all for Alzheimer’s disease, a degenerative mentality treachery affecting 18 million inhabitants overall and the third chief encouragement of annihilation down cardiovascular disease and cancer3. The crust patch is applied oncedaily to the put a bet on, coffer or upper arm of patients.
“Exelon patch represent a invigorating inventiveness that is to say designed definitely to pull together the desires of patients, caregivers and physician mixed up beside this shocking disease,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “The patch has be shown to new building assessment, soften on the side effects, and allow medication to be deliver through the skin into the bloodstream smoothly and continuously over and done with 24 hours, helping to finish optimal dose. All these benefits propose the sleeping for enhanced end result contained with patients,” Shannon said. The European Union acclamation, coming in a while after the US approval in July 2007, be foot on grades from the global IDEAL (Investigation of Transdermal Exelon in ALzheimer’s disease) hut, which involved nearly 1,200 patients with mild to clement Alzheimer’s disease1.
The patch express associated efficacy to the superlative dose of Exelon tablet, moreover in place of famous raise in reminiscence and the wherewithal to accomplish cliched appointments equate to placebo1.
The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a do away with appoint of The Henry J. Kaiser Family Foundation . 2005 Advisory Board Company and Kaiser Family Foundation. All rights self-effacing.
“The patch is an sizeable ambiguous addition to normal oral treatment option since it allot optical reassurance that patients have ‘taken’ their medicine,” said Bruno Dubois, Professor of Neurology at the Hôpital Pitié Salpétrière, Centre de Neuropsychologie, Paris, France. “Just be required to apply a patch can facilitate reduce the freight of on a daily basis time for people with Alzheimer’s disease and their people.” Designed with compliance in awareness, the patch was agreed by greater than 70% of caregivers as a attitude of pills rearrangement because it help them pursue treatment programme and was easier to waste than an oral medicine2. “People with Alzheimer’s disease and their caregivers reaction both new dream therapy for the disease,” said Mark Wortmann, Executive Director of Alzheimer’s Disease International - an umbrella direction of Alzheimer Associations in a circle the world which offer leg and guidance to people with the disease and their carers. “I am exhilarated that the patch offer a new brave to treatment.” Exelon (rivastigmine) in capsule form has been approved since 1997 to extravagance patients with mild to moderate Alzheimer’s disease in more than 70 country. Since 2006, Exelon in capsule form or oral medication has been the only stricture of the cholinesterase inhibitor mode of medicine that is approved in both Europe and the US for treat mild to moderate Alzheimer’s disease as adeptly as Parkinson’s disease dementia. On July 6, 2007, the US Food and Drug Administration (FDA) approved Exelon Patch (rivastigmine transdermal system) for the treatment of mild to moderate Alzheimer’s disease and Parkinson’s disease dementia. Alzheimer’s disease affect one in 10 people over age 65, making it the peak trade form of dementia3. The intercontinental lead costs of dementia in 2003, for case in point, be fairly accurate at USD 156 billion4.
Disclaimer The foregoing unchain encompass forward-looking authentication that can be identified by gobbledygook such as “potential”, “can”, “estimated”, or similar expressions, or by acquire across or implied planning in relative amount to potential studied revenues from Exelon Patch. Such forward-looking statements emulate the current view of the Company regarding future trial, and complex up with finicky and unknown risk, uncertainties and other factor that may cause actual results with Exelon Patch to be materially different from any future results, celebration or exploit expressed or implied by such statements. There can be no contract that Exelon Patch will achieve any particular stratum of revenue in the future. In particular, management’s expectations regarding Exelon Patch could be ostentatious by, among other things, unanticipated clinical consideration results, as well as unexpected new clinical info and unexpected supplementary analysis of existing clinical data; moodiness in model; diplomatic affairs, industry and general general population price pressure; the company’s ability ahead of you by or say exclusive rights or other proprietary highbrow chattels protection; unexpected regulatory actions or delay or government writ across the world, and other risks and factors referred to in Novartis AG’s current Form 20-F on profile with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumption prove in the wrong, actual results may change materially from those anticipated, believed, estimated or looked-for. Novartis is providing the information here grit release on or after this date and do not embark upon any duty to update any forwardlooking statements contained in this press release properly of new information, future events or otherwise.
About Novartis Novartis AG (NYSE: NVS) is a world commandant in offering medicines to lavish concern on outline, solution disease and promote well-being. Our aspiration is to uncover, get it mutually and victoriously gala innovative products to treat patients, effortlessness suffering and enhance the characteristic of life. We be fastness our medicine-based portfolio, which is harsh on strategic increase platform in innovation-driven pharmaceuticals, good quality and low-cost generics, human vaccines and leading self-medication OTC brand. Novartis is the only peace with police position in these area. In 2006, the Group’s business achieve net public sale of USD 37.0 billion and net assets of USD 7.2 billion. Approximately USD 5.4 billion was put into in R&D. Headquartered in Basel, Switzerland, Novartis Group company utilize more than 100,000 friends and operate in over 140 countries around the world. For more information, gratify call for in References 1. Winblad B, Cummings J, et al. A 6-Month Double-blind, Randomized, Placebo-Controlled Study of a Transdermal Patch in Alzheimer’s Disease - Rivastigmine Patch versus Capsule.
International Journal of Geriatric Psychiatry May 2007: 22: 5:485-491.
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3. Alzheimer’s Association. Alzheimer’s Disease Facts and Figures, 2007.
4. Wimo A, Jonsson L, Winblad B. An Estimate of the Worldwide Prevalence and Direct Costs of Dementia in 2003. Dementia and Geriatric Cognitive Disorders 2006; 21:175-181.
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