Claim: FDA Panel Backs Novartis Drug For Treating Parkinson’s Dementia
Verdict: REFUTES

Retrieved passages:
title: Tamas Bartfai
text: for 'heartburn', as a consultant to Roche, the catechol-O-methyltransferase inhibitor (Tasmar-tolcapone) used in Parkinson's Disease, the first benzodiazepine–antagonist (flunitrazepam) for treatment of benzodiazepine overdoses, and as a consultant to Novartis the sphingosine 1-phosphate agonist gilenya-fingolimod as the first oral multiple sclerosis drug. He has also worked on four current drug candidates that as of 2015, are in phase 2 and 3 clinical trials. One of the most promising ones is the amyloid Αβ antibody that the Banner Alzheimer's Institute, Roche and the U.S. government are testing in Colombia for prevention of Alzheimer's disease in a large cohort with a familial

title: Pimavanserin
text: people with Parkinson's disease on April 29, 2016. In July 2018 the FDA approved a new capsule dose formulation and tablet strength of pimavanserin to treat hallucinations and delusions associated with Parkinson’s disease psychosis in a 34-mg single capsule formulation. On April 9, 2018, CNN reported that some in the FDA were concerned that Nuplazid was "risky" when it was approved and noted there have been a substantial number of deaths reported by those using the drug. The story further noted that the drug was approved based on a "six-week study of about 200 patients". The FDA began post-market monitoring

title: Donepezil
text: Eisai received approval from the United States Food and Drug Administration (USFDA) for donepezil under the brand "Aricept", which it co-marketed with Pfizer. The team at Eisai was led by Hachiro Sugimoto As of 2011, Aricept was the world's best-selling Alzheimer's disease treatment. The first generic donepezil became available in November 2010 with the USFDA approval of a formulation prepared by Ranbaxy Labs. In April 2011 a second generic formulation, from Wockhardt, received tentative USFDA marketing approval. Donepezil has been tested in other cognitive disorders, including Lewy body dementia, and vascular dementia, but it is not currently approved for these

title: Nilotinib
text: 2011 that it was discontinuing a phase III trial of Tasigna (nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumor (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Novartis's Gleevec (imatinib)*, the current standard of care in this setting. The use of low doses of nilotinib is being investigated for use for Parkinson's, and Alzheimer's disease, as well as for ALS, dementia and Huntington's disease. Beginning in 2015, nilotinib was being trialed in people with Parkinson's disease as it appeared to be able

title: Rasagiline
text: share the costs and obtained the joint right to market the drug in Europe. In 2003 Teva partnered with Eisai, giving Eisai the right to jointly market the drug for Parkinson's in the US, and to co-develop and co-market the drug for Alzheimers and other neurological diseases. It was approved by the European Medicines Agency for Parkinson's in 2005 and in the US in 2006. Rasagiline was tested for efficacy in people with multiple system atrophy in a large randomized, placebo-controlled, double-blind disease-modification trial; the drug failed. Teva conducted clinical trials attempting to prove that rasagiline did not just treat

title: Neurolixis
text: Parkinson's UK announced that it had awarded Neurolixis a grant to advance development of befiradol up to clinical phase in Parkinson's disease patients. F-15599 (also known as NLX-101) was awarded Orphan Drug Status by the United States Food and Drug Administration (FDA) in October 2013 and Orphan Medicinal Product designation by the European Medicines Agency in March 2014. In collaboration with researchers at the University of Bristol, Neurolixis has been awarded a grant by the International Rett Syndrome Foundation to study F-15599 in animal models of Rett syndrome. In June 2015, Neurolixis was awarded a grant by the Rett Syndrome

title: Neurocrine Biosciences
text: the treatment of pediatric patients with Tourette syndrome. In February 2017, Neurocrine announced an exclusive licensing agreement for the development and commercialization of the Parkinson's disease drug, opicapone, in North America with the Portugal-based pharmaceutical company Bial. As part of the agreement, Neurocrine provided an upfront payment of $30 million and agreed to fund development activities for FDA approval in the United States. Bial is eligible to receive additional milestone payments of up to $115 million and a percentage of net sales. In September 2017, AbbVie submitted a NDA to the FDA for elagolix for the management of endometriosis and

title: Kenneth L. Davis
text: Mount Sinai Health System. Davis has weighed in on the intersection of health and public policy, arguing that the National Institutes of Health should receive more funds to fight disease and calling drug prices 'outrageous' and a fair trade issue. Davis participated in breakthrough proof-of-concept studies and clinical trials of cholinesterase inhibitors. These trials (the first multicenter ones for cholinesterase inhibitors) established efficacy and ultimately led the first four of the five FDA-approved compounds for treating the symptoms of Alzheimer's: tacrine, rivastigmine, galantamine, donepezil and memantine In 1978, Davis, together with Richard Mohs, conducted the first well-controlled study of a

title: Memory and aging
text: years. There are four drugs currently approved by the FDA for the treatment of Alzheimer’s, and they all act on the cholinergic system: Donepezil, Galantamine, Rivastigmine, and Tacrine. Although these medications are not the cure for Alzheimer’s, symptoms may be reduced for up to eighteen months for mild or moderate dementia. These drugs do not forestall the ultimate decline to full Alzheimer's. Also, modality is important in determining the strength of the memory. For instance, auditory creates stronger memory abilities than visual. This is shown by the higher recency and primacy effects of an auditory recall test compared to that

title: Etanercept
text: disorders. The company's April 17, 2013 press release claimed that the biosimilar will cost 30% less as compared to the innovator. In January 2015, Samsung and Biogen's joint venture "Samsung Bioepis" successfully submitted Benepali, a biosimilar version of the drug, for review to the European Medicines Agency (EMA), and announced that it will seek regulatory approvals in other territories as well. Later the same year, the European Medicines Agency also accepted Sandoz’s application for review of its etanercept biosimilar Erelzi which will be marketed by Novartis. In the U.S., Sandoz submitted a biologics license application (BLA) for the proposed etanercept

title: Parkinson's disease clinical research
text: disorders. Several molecules have been proposed as potential neuroprotective treatments. However none of them has been conclusively demonstrated to reduce degeneration in clinical trials. Agents currently under investigation as neuroprotective agents include anti-apoptotic drugs (omigapil, CEP-1347), antiglutamatergic agents, monoamine oxidase inhibitors (selegiline, rasagiline), promitochondrial drugs (coenzyme Q10, creatine), calcium channel blockers (isradipine) and growth factors (GDNF). Researchers are also investigating vaccines for Parkinson's disease that produce cells that change the way the body's immune system responds to the loss of dopamine. This treatment has shown success in reversing Parkinson's in mice, and researchers are investigating the viability of clinical studies

title: Solanezumab
text: (NCT01900665). Patients with mild Alzheimer’s disease received 400 mg solanezumab every 4 weeks for 80 weeks. Afterwards they can continue treatment for a total of 208 weeks, if wanted. This trial failed to show positive results, despite the high expectations. The trial will be finalized in 2020. Solanezumab Solanezumab (proposed INN, LY2062430) is a monoclonal antibody being investigated by Eli Lilly as a neuroprotector for patients with Alzheimer's disease. The drug originally attracted extensive media coverage proclaiming it a breakthrough, but it has failed to show promise in Phase III trials. Solanezumab was safely used in combination with approved Alzheimer’s

title: Rasagiline
text: symptoms, but was a disease-modifying drug - that it actually prevented the death of the dopaminergic neurons that characterize Parkinson's disease and slowed disease progression. They conducted two clinical trials, called TEMPO and ADAGIO, to try to prove this. The FDA advisory committee rejected their claim in 2011, saying that the clinical trial results did not prove that rasagiline was neuroprotective. The main reason was that in one of the trials, the lower dose was effective at slowing progression, but the higher dose was not, and this made no sense in light of standard dose-response pharmacology. Rasagiline Rasagiline (Azilect, TVP-1012,

title: Management of Parkinson's disease
text: PD, but since the quality of evidence on efficacy is reduced, they are not first-choice treatments. In addition to motor symptoms, PD is accompanied by a range of different symptoms. Different compounds are used to improve some of these problems. Examples are the use of clozapine for psychosis, cholinesterase inhibitors for dementia, modafinil for day somnolence, and atomoxetine for executive dysfunction. A preliminary study indicates taking donepezil (Aricept) may help prevent falls in people with Parkinson's. Donepezil boosts the levels of the neurotransmitter acetylcholine, and is currently an approved therapy for the cognitive symptoms of Alzheimer's disease. In the study,

title: Remacemide
text: mentioned in AstraZeneca's reports on its R&D pipeline in 2000, when it was in Phase III clinical trials for remacemide in the treatment of Huntington's disease and Phase II for treatment of Parkinson's disease. At that time, the submission of the New Drug Application (NDA) to the FDA and the Marketing Authorization Application to the CHMP was projected for Huntington's in 2001 and for Parkinson's after 2003, but there has been no news of such submission. In this report, it was also noted that remacemide was "under strategic review and a potential candidate for licensing activity" (see this external article

title: Alzheimer's disease research
text: patients. Because of that Alzheimer's disease has been called Type 3 diabetes and the insulin modification therapies are in pharmaceutical's pipelines. Several other pharmaceuticals are under investigation to treat Alzheimer's disease. Allopregnanolone has been identified as a potential drug agent. Levels of neurosteroids such as allopregnanolone decline in the brain in old age and AD. Allopregnanolone has been shown to aid the neurogenesis that reverses cognitive deficits in a mouse model of AD. A retrospective analysis of five million patient records with the US Department of Veterans Affairs system found that different types of commonly used anti-hypertensive medications had very

title: Neurocrine Biosciences
text: agreed to pay Neurocrine $74 million over five years to develop drugs for obesity and Alzheimer's disease based on its research of CRF-binding protein-ligand inhibitors. In July 2001, Neurocrine and GlaxoSmithKline entered into a worldwide research, development and commercialization agreement, including a collaborative research program for up to five years to identify and develop CRF-R antagonist compounds. The collaboration also included worldwide development and commercialization of NBI-34041 as well as potential backup candidates resulting from the research program. Neurocrine received upfront fees and early milestone payments totaling $25.5 million. In December 2002, Neurocrine reached an agreement with Pfizer for the

title: Valsartan
text: Alzheimer's disease and dementia. Valsartan is combined with amlodipine or HCTZ (or both) into single-pill formulations for treating hypertension with multiple drugs. On July 6, 2018, the European Medicines Agency recalled certain batches of valsartan and valsartan/HCT film-coated tablets distributed in 22 countries in Europe, plus Canada. Zhejiang Huahai Pharmaceutical Co. (ZHP) in Linhai, China manufactured the bulk ingredient contaminated by N-nitrosodimethylamine (NDMA), a carcinogen. The active pharmaceutical ingredient was subsequently imported by a number of generic drugmakers, including Novartis, and marketed in Europe and Asia under their subsidiary Sandoz labeling, and in the UK by Dexcel Pharma Ltd and

title: Erythropoietin in neuroprotection
text: disorder. Specifically in mice, Epo demonstrated protective effects on nigral dopaminergic neurons in a mouse model of Parkinson's Disease. This recent experiment tested the hypothesis that RhEpo could protect dopaminergic neurons and improve the neurobehavioral outcome in a rat model of Parkinson's Disease. The intrastriatal administration of RhEpo significantly reduced the degree of rotational asymmetry, and the RhEpo-treated rats demonstrated improvement in skilled forearm use. These experiments demonstrated that intrastriatal administration of RhEpo can protect nigral dopaminergic neurons from 6-OHDA induced cell death and improve neurobehavioral outcome in a rat model of Parkinson's Disease. Currently methylprednisolone (Medrol) is only pharmaceutical

title: William K. Summers
text: I, placed Summers on a secret "black list" without informing him. Once discovered by Summers, in 2007, the citation was removed. When Summers initiated his research, it was commonly accepted that Alzheimer’s disease was a progressive unremitting neurodegenerative disease that could not be improved. Today, there are five FDA approved medications for the treatment of Alzheimer’s or Dementia of other types. In 2011, there are 842 Clinical trials on over 100 drugs under investigation for the treatment of Alzheimer’s disease. Since the 1980s, the majority of research effort was focused on the genetics and toxicity of beta amyloid protein as