{"id":1734,"date":"2021-07-02T14:11:09","date_gmt":"2021-07-02T18:11:09","guid":{"rendered":"https:\/\/allhomecarematters.com\/?p=1734"},"modified":"2023-06-15T14:28:03","modified_gmt":"2023-06-15T18:28:03","slug":"the-fda-approve-first-drug-for-alzheimers-in-18-years","status":"publish","type":"post","link":"https:\/\/allhomecarematters.com\/the-fda-approve-first-drug-for-alzheimers-in-18-years\/","title":{"rendered":"The FDA approve first drug for Alzheimer\u2019s in 18 years"},"content":{"rendered":"
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The Food and Drug Administration in the United States have, on Monday 7 June 2021, approved the use of ADUCANUMAB, an experimental drug used for the early stages of Alzheimer\u2019s disease. This is the first drug for Alzheimer\u2019s that the FDA has approved in 18 years\u2026<\/p>\n

With such MASSIVE news we thought it was important to share the news and although it is an extremely controversial decision, we wanted to set out some facts.<\/p>\n

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Just a note:\u00a0<\/i>We are by no means a leading authority on drug therapy or medications but we do think it is important that EVERYONE has all the information available to make an informed decision of their own. We would of course advise anyone to take individual advice and consult their doctors and medical team. This medication (discussed in this article) is only available in the US at present.<\/i><\/p>\n

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The decision by the FDA is somewhat controversial, following the FDA Advisory Committee last year stating that there was not enough evidence to demonstrate that the treatment was effective.<\/p>\n

Aducanumab, also known as Aduhelm, was developed for individuals with mild cognitive impairment, as opposed to severe Dementia, with the aim of slowing the progression of Alzheimer\u2019s disease. The drug has been approved using the FDA\u2019s accelerated program, used for the approval of drugs for life-threatening or serious illnesses although it is acknowledged that more studies may be necessary in the future.<\/p>\n

Dr. Patrizia Cavazzoni, director of the FDA\u2019s Center for Drug Evaluation and Research, stated:<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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There has been considerable public debate on whether Aduhelm should be approved…we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward…concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy…FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s<\/p>\n<\/blockquote>\n<\/div>\n<\/div>\n

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As stated, the FDA will continue to monitor the use of the drug and post-approval studies will be carried out to verify the benefits of using the drug, which could lead to the FDA removing the drug from the market if necessary.<\/p>\n

When considering the benefits of the drug, Dr. Patrizia Cavazzoni, director of the FDA\u2019s Center for Drug Evaluation and Research, stated:<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion…It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.<\/p>\n<\/blockquote>\n<\/div>\n<\/div>\n

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It is important to note that the studies conducted concentrated on the early phases of Alzheimer\u2019s disease and this should be borne in mind when managing expectations of the drug usage as this is a drug developed for the earliest phases of Alzheimer\u2019s and not individuals with severe symptoms.<\/p>\n

In addition, the cost of the drug is extremely high and is another point of controversy for many. For a high dose of the drug (that requires infusion every four-weeks) the cost is approximately $4,312 for each infusion, meaning the annual cost is around $56,000! The developers have stated that they are committed to making the drug available across all patients (regardless of their finances) and there are assistance programs available as well as medical plans that may reduce the cost to individuals to zero, however we will await to see the results.<\/p>\n

Much controversy surrounds the approval by the FDA, including from nonprofit organisations due to the lack of evidence in relation to the effectiveness but as with any new drug, this may take time to evaluate. It is however, worth noting that the Alzheimer\u2019s Association have supported the approval of the drug by the FDA and CEO of Alzheimer\u2019s Association, Harry Johns, stated:<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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This approval is a victory for people living with Alzheimer’s and their families<\/p>\n<\/blockquote>\n<\/div>\n<\/div>\n

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Just a note:\u00a0<\/i>We are by no means a leading authority on drug therapy or medications but we do think it is important that EVERYONE has all the information available to make an informed decision of their own. We would of course advise anyone to take individual advice and consult their doctors and medical team. This medication (discussed in this article) is only available in the US at present.<\/i><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration in the United States have, on Monday 7 June 2021, approved the use of ADUCANUMAB, an experimental drug used for the early stages of Alzheimer\u2019s disease. This is the first drug for Alzheimer\u2019s that the FDA has approved in 18 years\u2026 With such MASSIVE news we thought it was important to […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[9],"tags":[],"class_list":["post-1734","post","type-post","status-publish","format-standard","hentry","category-dementiatlc-posts"],"_links":{"self":[{"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/posts\/1734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/comments?post=1734"}],"version-history":[{"count":0,"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/posts\/1734\/revisions"}],"wp:attachment":[{"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/media?parent=1734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/categories?post=1734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allhomecarematters.com\/api-rest\/wp\/v2\/tags?post=1734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}