{"id":556372,"date":"2021-06-07T23:20:47","date_gmt":"2021-06-08T03:20:47","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=556372"},"modified":"2021-06-07T23:20:50","modified_gmt":"2021-06-08T03:20:50","slug":"fda-approves-alzheimers-drug-for-first-time-in-years","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-approves-alzheimers-drug-for-first-time-in-years\/","title":{"rendered":"FDA Approves Alzheimer\u2019s Drug For First Time In Years"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">18<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-approves-alzheimers-drug-for-first-time-in-years%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=556372&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div><img decoding=\"async\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2021\/06\/GettyImages-840306994-1200x800-1.jpg\" class=\"ff-og-image-inserted\"  style=\"display:none\"><\/div>\n<p><span>The Food and Drug administration approved a new drug for Alzheimer\u2019s disease Monday, purportedly giving doctors a new but much-debated method of directly addressing the Alzheimer\u2019s disease process instead of merely treating the symptoms of it.\u00a0<\/span><\/p>\n<p><span>The drug, called aducanumab, was approved through the FDA\u2019s <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/information-health-care-professionals-drugs\/accelerated-approval-program\"><span>accelerated approval<\/span><\/a><span> program, which is reserved for drugs that \u201cfill an unmet medical need based on a surrogate endpoint\u201d but that do not definitively improve patient outcomes. As <\/span><a href=\"https:\/\/www.statnews.com\/2021\/06\/07\/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline\/\"><span>Stat News<\/span><\/a><span> notes, this means that, while the drug has shown it can eliminate the toxic protein clumps experts believe contribute to dementia, the regulatory agency doesn\u2019t know definitively if it actually helps improve cognition in the patients who receive it.\u00a0<\/span><\/p>\n<p><span>\u201cAlzheimer\u2019s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,\u201d <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-alzheimers-drug\"><span>said<\/span><\/a><span> Patrizia Cavazzoni, M.D., director of the FDA\u2019s Center for Drug Evaluation and Research. \u201cCurrently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer\u2019s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.\u201d<\/span><\/p>\n<p><span>According to <\/span><a href=\"https:\/\/www.nytimes.com\/2021\/06\/07\/health\/aduhelm-fda-alzheimers-drug.html?action=click&#038;module=Top%20Stories&#038;pgtype=Homepage\"><span>The New York Times<\/span><\/a><span>, both proponents and critics of the drug, which also goes by the brand name Aduhelm, agree that it \u201csubstantially reduces levels of amyloid,\u201d a protein that \u201cclumps into plaques in the brains of Alzheimer\u2019s patients and is considered a biomarker of the disease.\u201d But in the past, drugs that have reduced amyloid levels in patients have still failed to improve outcomes in patients.\u00a0<\/span><\/p>\n<p>\u201cThere\u2019s so little evidence for effectiveness,\u201d said Dr. Lon Schneider, director of the California Alzheimer\u2019s Disease Center at the University of Southern California, who helped conduct one of the aducanumab trials, told the New York Times. He added: \u201cI don\u2019t know what caught the F.D.A.\u2019s fancy here.\u201d<\/p>\n<p>But Harry Johns, chief executive of the Alzheimer\u2019s Association, called the approval a \u201cvictory for people living with Alzheimer\u2019s and their families.\u201d<\/p>\n<p>\u201cThis is the first FDA-approved drug that delays decline due to Alzheimer\u2019s disease,\u201d said Johns in a <a href=\"https:\/\/www.alz.org\/news\/2021\/alzheimers-association-fda-approval-aducanumab\">statement<\/a>. \u201cThis means individuals may have more time to actively participate in daily life, have sustained independence and hold on to memories longer. We can experience longer \u2014 the relationships we hold most dear \u2014 our families and friends.\u201d<\/p>\n<p><span>From Stat News:\u00a0<\/span><\/p>\n<blockquote readability=\"18\">\n<p><i><span>For decades, scientists who study Alzheimer\u2019s have focused much of their research on amyloid. A succession of companies including Eli Lilly, Pfizer, Roche, and Merck have attempted to treat Alzheimer\u2019s with various types of antibody drugs that work by targeting and eliminating beta-amyloid \u2014 all without success.<\/span><\/i><\/p>\n<p><i><span>Biogen believed it could succeed where the others failed; it designed Aduhelm to be more potent and therefore better able to eliminate amyloid plaques than earlier drugs. The company also focused on administering Aduhelm to people with mild cognitive impairment or the earliest signs of Alzheimer\u2019s, before brain cells were too damaged to stem the tide of the disease.<\/span><\/i><\/p>\n<\/blockquote>\n<p>An FDA advisory committee voiced opposition to the drug\u2019s approval in November. However, the FDA isn\u2019t required to listen to the committee.<\/p>\n<p><span>Biogen, the maker of the drug, has estimated it will list at $56,000 per year \u2014 which does not necessarily reflect the actual price patients or insurance will pay. According to Stat News, analysts believe the price will be between $10,000 and $25,000 per year for patients. The drug is administered intravenously once every four weeks.\u00a0\u00a0<\/span><\/p>\n<p><span>Michel Vounatsos, CEO of Biogen, defended the price of the drug Monday, reportedly telling <\/span><a href=\"https:\/\/www.cnbc.com\/2021\/06\/07\/biogen-ceo-says-56000-annually-for-alzheimers-drug-is-fair-promises-not-to-hike-price-for-at-least-4-years.html\"><span>CNBC<\/span><\/a><span> that the list price was \u201cfair.\u201d He also called the drug the product of \u201ctwo decades of innovation.\u201d The last Alzheimer\u2019s drug was approved by the FDA in 2003.\u00a0<\/span><\/p>\n<p><span>\u201cWe feel a great sense of purpose and responsibility to turn the hope of today\u2019s FDA approval of [Aduhelm] into a reality for people living with Alzheimer\u2019s disease and their families,\u201d <\/span><a href=\"https:\/\/investors.biogen.com\/news-releases\/news-release-details\/biogen-and-eisai-launch-multiple-initiatives-help-patients\"><span>said<\/span><\/a><span> Alisha Alaimo, President of Biogen U.S. \u201cWe are committed to access and health equity as top priorities and will continue working with multiple stakeholders with the goal of helping patients who may benefit from treatment obtain care as quickly as possible.\u201d<\/span><\/p>\n<p><span>Under the FDA accelerated approval rules, the drug-maker will still need to conduct stage IV clinical trials to prove that Aduhelm provides a clinical benefit to Alzheimer\u2019s patients. \u201cIf the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug,\u201d notes the FDA. \u201cIf the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.\u201d<\/span><\/p>\n<p><i><span>The Daily Wire is one of America\u2019s fastest-growing conservative media companies and counter-cultural outlets for news, opinion, and entertainment. Get inside access to The Daily Wire by becoming a member.<\/span><\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug administration approved a new drug for Alzheimer\u2019s disease Monday, purportedly giving doctors a new but much-debated method of directly addressing the Alzheimer\u2019s disease process instead of &#8230;<\/p>\n","protected":false},"author":1,"featured_media":2279564,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2021\/06\/GettyImages-840306994-1200x800-1.jpg","fifu_image_alt":"FDA Approves Alzheimer\u2019s Drug For First Time In Years","footnotes":""},"categories":[],"tags":[],"class_list":["post-556372","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"fifu_image_url":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2021\/06\/GettyImages-840306994-1200x800-1.jpg","fifu_image_alt":"FDA Approves Alzheimer\u2019s Drug For First Time In Years","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/556372","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=556372"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/556372\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2279564"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=556372"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=556372"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=556372"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}