{"id":566513,"date":"2021-06-23T13:33:57","date_gmt":"2021-06-23T13:33:57","guid":{"rendered":"https:\/\/enterpriseam.com\/egypt\/2021\/06\/23\/is-new-alzheimers-drug-a-groundbreaking-treatment-or-the-fdas-biggest-mistake\/"},"modified":"2021-06-23T13:33:57","modified_gmt":"2021-06-23T13:33:57","slug":"is-new-alzheimers-drug-a-groundbreaking-treatment-or-the-fdas-biggest-mistake","status":"publish","type":"post","link":"https:\/\/enterpriseam.com\/egypt\/2021\/06\/23\/is-new-alzheimers-drug-a-groundbreaking-treatment-or-the-fdas-biggest-mistake\/","title":{"rendered":"Is new Alzheimer\u2019s drug a groundbreaking treatment, or the FDA\u2019s biggest mistake?"},"content":{"rendered":"

<\/a> When the first new Alzheimer\u2019s drug in 20 years was approved by the FDA earlier <\/strong>this month, many expected the celebration of this small victory against a devastating disease. <\/strong>Instead, a string of resignations followed from members of the committee who had reviewed and evaluated the safety and effectiveness of the drug. They protested that the new medicine \u2014 aducanumab, known by the shelf name Aduhelm \u2014 was both unsafe, and had shown no real efficacy against the cognitive dementia caused by the disease.<\/p>\n

So what exactly is this new drug? <\/strong>Researchers believe that aducanumab attacks the amyloid-protein plaques that impair the cognitive function of the brain. High doses of the drug seemed to be effective at slowing cognitive decline for early-stage patients, though further study was recommended.<\/p>\n

Did the trials at least have promising results? <\/strong>Absolutely not. During the clinical trials, about 42% of patients experienced brain swelling or bleeding after the first dose. The prohibitive cost of the drug, a whopping USD 56k a year, has also sparked outrage.<\/p>\n

What do the experts say? <\/strong>The Peripheral and Central Nervous System Drugs Advisory Committee had advised against approving the drug after finding no sufficient evidence that it could actually impede the cognitive decline of dementia, according to The New Yorker<\/a>. Ten committee members voted no, one voted uncertain, while another abstained. With not a single vote in favor of the medicine from a committee of experts, why did the FDA approve it anyways?<\/p>\n

The prevalence of the disease may have something to do with it:<\/strong> Alzheimer's is ranked as the sixth leading cause of death in the US, and is the primary cause of dementia, which affects an estimated 50 mn people worldwide, according to World Health Organization<\/a> estimates. The quest for an Alzheimer\u2019s treatment has been high on medical researchers\u2019 agendas for decades, with the first treatment for the disease trialled in 1987<\/a> and bns of dollars pumped into global research since. The global societal cost of dementia in 2015 was estimated at USD 818 bn, equivalent to 1.1% of global GDP.<\/p>\n

Desperate for a solution, the FDA seems to have ignored conventional wisdom: <\/strong>Aducanumab was approved using the authority\u2019s \u201cAccelerated Approval Pathway,\u201d which OKs drugs that fill unmet medical needs based on indications \u2014 not guarantees \u2014 that they are likely to have clinical benefits.<\/p>\n

The FDA\u2019s perspective: <\/strong>In a statement<\/a>, the FDA said it anticipated \u201can expectation of clinical benefit,\u201d from the drug\u2019s approval, and that it believed that \u201cthe benefits [of aducanumab] for patients with Alzheimer's disease outweighed the risks of the therapy.\u201d The FDA also said it would require the manufacturer Biogen to conduct further clinical trials to verify the drug\u2019s safety and efficacy, and could remove it from the market if it proves ineffective.<\/p>\n

Besides, some say they have found the medicine helpful: <\/strong>A 68-year-old patient who was part of the trials said that the drug helped him feel less confused, with his family also noticing improvement, according to the BBC<\/a>. Meanwhile, the first Alzheimer\u2019s patient outside a trial context received the first dose of the intravenous drug last week.<\/p>\n

Our take:<\/strong> It\u2019s likely too early to tell, but the FDA seems to have jumped the gun on this one, potentially putting the public at risk. Still, no treatment comes without its risks and side-effects, and the possibility that this medicine may make life a little more bearable for Alzheimer\u2019s sufferers and their loved ones likely informed the FDA\u2019s decision.<\/p>\n","protected":false},"excerpt":{"rendered":"

When the first new Alzheimer\u2019s drug in 20 years was approved by the FDA earlier this month, many expected the celebration of this small victory against a devastating disease. Instead, a string of resignations followed from members of the committee who had reviewed and evaluated the safety and effectiveness of the drug. They protested that […]<\/p>\n","protected":false},"author":1,"featured_media":566514,"comment_status":"closed","ping_status":"open","sticky":false,"template":"single-feature.php","format":"standard","meta":{"_acf_changed":false,"newspack_ads_suppress_ads":false,"newspack_popups_has_disabled_popups":false,"newspack_sponsor_sponsorship_scope":"","newspack_sponsor_native_byline_display":"inherit","newspack_sponsor_native_category_display":"inherit","newspack_sponsor_underwriter_style":"inherit","newspack_sponsor_underwriter_placement":"inherit","ep_exclude_from_search":false,"_primary_brand":0,"newspack_featured_image_position":"","newspack_post_subtitle":"","newspack_article_summary_title":"Overview:","newspack_article_summary":"","newspack_hide_updated_date":false,"newspack_show_updated_date":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[7304],"tags":[633,379,427],"brand":[],"newspack_spnsrs_tax":[],"class_list":["post-566513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma","tag-enterprisepm","tag-fda","tag-pharma","wpautop","entry"],"acf":{"mongo_id":"106e784f-7d55-489f-aa4e-03e4407d639e","is_powered_by":true,"story_type":"1","photo_url":"https:\/\/ent.news\/2021\/6\/573.jpg","photo_position":"above","related_issue":[566501],"teaser":"","voice_url":""},"yoast_head":"\nIs new Alzheimer\u2019s drug a groundbreaking treatment, or the FDA\u2019s biggest mistake? - EnterpriseAM Egypt<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/enterpriseam.com\/egypt\/2021\/06\/23\/is-new-alzheimers-drug-a-groundbreaking-treatment-or-the-fdas-biggest-mistake\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Is new Alzheimer\u2019s drug a groundbreaking treatment, or the FDA\u2019s biggest mistake?\" \/>\n<meta property=\"og:description\" content=\"When the first new Alzheimer\u2019s drug in 20 years was approved by the FDA earlier this month, many expected the celebration of this small victory against a devastating disease. 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Talaat said the drug, which will target patients who have not responded to available treatments such as Sovaldi, is\u2026","rel":"","context":"In "Health + Education"","block_context":{"text":"Health + Education","link":"https:\/\/enterpriseam.com\/egypt\/category\/health-education\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/ent.news\/internal\/536550.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":574104,"url":"https:\/\/enterpriseam.com\/egypt\/2020\/08\/30\/egyptian-drug-authority-to-grant-incentives-to-pharma-companies-for-export-bound-contract-manufacturing\/","url_meta":{"origin":566513,"position":4},"title":"Egyptian Drug Authority to grant incentives to pharma companies for export-bound contract manufacturing","author":"enterpriseam admin","date":"30 August 2020","format":false,"excerpt":"The Egyptian Drug Authority is looking to provide a set of incentives to contract manufacturing for export markets, said Egyptian Drug Authority spokesperson Aly El Ghamrawy according to a cabinet statement. 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