Novartis withdraws application for Exelon/Prometax extended indications

The Medical Technology Blog

Drug Delivery Insight Update

The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for  Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.

In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.

The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.

Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.

 



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UC Davis Study Identifies Early Alzheimer’s Risk Method!

The Medical Technology Blog

Hello once again to The Medical Technology Blog. A couple of weeks ago I posted an article concerning the Early Detection of Alzheimer’s Disease (AD) using Eye-Imaging, and today I have another post that also concerns the early identification of Alzheimer’s, using a different method. I apologise if I appear to be concentrating on Alzheimer’s, but as I said before, I think it a horrendous disease. An uncle of mine suffered from AD and by the time he was admitted to a specialist home for Alzheimers sufferers, he could neither recognize his wife, nor my mother, it was heartbreaking for them both. I welcome any study into this disease, please read on….

A study by researchers at the University of California Davis has found that abnormal brain images combined with examination of the composition of the fluid that surrounds the spine may offer the earliest signs identifying healthy older adults at risk of developing Alzheimer’s disease (AD), well before cognitive problems emerge. Published in the journal Neurobiology of Aging, the study analysis identified a subgroup of healthy adults who would later experience a decline in memory performance typical of early AD long before other study participants.

For the study, the scientists used data from the Alzheimer’s Disease Neuro-imaging Initiative, which provides researchers with access to brain scans, clinical data and other laboratory results from spinal fluid and blood tests from more than 800 older adults. Some study participants began with a clean slate of cognitive health, some with mild cognitive impairment, and others with mild or moderate AD.

The researchers analysed data from 220 normal older adults who had undergone structural MRI and clinical examinations, and approximately half also provided spinal fluid samples. Among the 96 participants, cluster analysis identified three distinct subgroups of individuals based solely on their baseline imaging and laboratory measures. Over the next three years, few of these healthy individuals showed any cognitive change. However, cognitive tests for people in one of the subgroups – approximately 10 per cent of the sample – declined at nearly five times the rate as healthy older adults. The researchers believe this group, which had the most extreme MRI and spinal fluid measurements, may represent the earliest stages of subclinical cognitive decline and AD.

The finding is said to be an important step towards discovering the constellation of imaging and fluid biomarkers that foreshadow cognitive decline, as well as a means of determining whether new treatments are effective. It is believed that this method could improve clinical trials for prevention and reduce the numbers of study participants necessary to speed drug discovery – and eventually change how the pharmaceutical industry and National Institutes of Health conduct AD clinical trials.

According to Laurel Beckett, a professor of public health sciences at UC Davis and the lead study author, these findings indicate that a distinctive pattern of imaging and biomarker deviations from typical adults may be an early warning sign of neurobiological pathology and an early sign of AD. By the time people are diagnosed with AD using cognitive tests, there is already a lot of brain damage. It is therefore hoped that future methods combining brain imaging and biomarker assessments can enable earlier diagnosis, while learning more about the mechanisms causing AD so that better treatments can be developed.

Thank you for reading, please check back soon, and feel free to  leave a comment and your name, with a link back to your own site or blog.

Regards, Paul



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