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VOA \u2014 An experimental Alzheimer’s drug developed by Eisai and Biogen significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, the companies said Tuesday.<\/p>\nVOA \u2014 An experimental Alzheimer’s drug developed by Eisai and Biogen significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, the companies said Tuesday.<\/p>\n
The injected drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal and offering an apparent win for the companies and potentially for patients and their families desperate for an effective treatment.<\/p>\n
Eisai said the results from the 1,800-patient trial prove the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can delay advance of the debilitating disease.<\/p>\n
“It’s not a huge effect, but it’s a positive effect,” said Ronald Petersen, director of the Mayo Clinic Alzheimer\u2019s Disease Research Center in Rochester, Minnesota, adding that the results were extremely important for Alzheimer’s research.<\/p>\n
“This means that treating amyloid is a step in the right direction,” he said.<\/p>\n
Results considered a “win”<\/strong><\/p>\n Wall Street analysts, such as Salim Syed at Mizuho Securities, have said the results would be considered a “win” if lecanemab slowed the rate of decline by about 25%, and that shares of both companies could jump on the news.<\/p>\n Shares of Biogen and Eisai were halted, but shares of Eli Lilly, which is also developing an Alzheimer’s drug, were up 6.7% in after-hours trading.<\/p>\n Lecanemab, like the companies’ previous drug Aduhelm, is an antibody designed to remove those amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.<\/p>\n The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.<\/p>\n Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of high-profile failures for the industry.<\/p>\n Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval under the same accelerated pathway as Aduhelm, with a decision expected in early January. But on Tuesday, the Japanese drugmaker said it would use the new efficacy results to submit lecanemab for traditional FDA review.<\/p>\n The company said it will also seek authorization in Japan and Europe during its current fiscal year, ending March 31.<\/p>\n The Phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem-solving and personal care.<\/p>\n Brain swelling<\/strong><\/p>\n The rate of ARIA-E, a brain swelling side effect associated with anti-amyloid treatments, was 12.5% in the lecanemab group, versus 1.7% in the placebo group.<\/p>\n While the side effect showed up on imaging, many of these cases were not symptomatic, the companies said. Symptomatic brain swelling was seen in 2.8% of those in the lecanemab group and none of the placebo group, they said.<\/p>\n The trial also tracked the rate of micro hemorrhages in the brain, which occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group.<\/p>\n The total incidence of both conditions was 21.3% in the lecanemab group and 9.3% in the placebo group, rates that fell within an expected range, the companies said.<\/p>\n Petersen said the side effect was present, but much less than with Aduhelm, and “certainly tolerable.”<\/p>\n Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.<\/p>\n The controversy and reluctance by some payers to cover Aduhelm led Biogen to slash the drug’s price to $28,000 per year from an initial $56,000.<\/p>\n But Medicare, the U.S. government health plan for people 65 and older, this year said it would only pay for Aduhelm if patients were enrolled in a valid clinical trial, which sharply curtailed the medication’s use. Since Alzheimer’s is a disease of aging, an estimated 85% of patients eligible for the drug are covered by the government plan.<\/p>\n The number of Americans living with Alzheimer’s is expected to rise to about 13 million by 2050 from more than 6 million currently, according to the Alzheimer’s Association. Globally, that figure could rise to 139 million by 2050 without an effective treatment, according to Alzheimer’s Disease International.<\/p>\n","protected":false},"excerpt":{"rendered":" VOA \u2014 An experimental Alzheimer’s drug developed by Eisai and Biogen significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, the companies said Tuesday. The injected drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal […]<\/p>\n","protected":false},"author":1,"featured_media":105982,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[16],"tags":[],"class_list":["post-105981","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recposts"],"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fa","en"],"languages":{"fa":{"title":true,"content":true,"excerpt":false},"en":{"title":false,"content":false,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/posts\/105981","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/comments?post=105981"}],"version-history":[{"count":2,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/posts\/105981\/revisions"}],"predecessor-version":[{"id":105984,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/posts\/105981\/revisions\/105984"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/media\/105982"}],"wp:attachment":[{"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/media?parent=105981"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/categories?post=105981"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/PERSIAN-HERITAGE.COM\/en\/wp-json\/wp\/v2\/tags?post=105981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n\n![\"FILE::](\"https:\/\/gdb.voanews.com\/03990000-0aff-0242-cf59-08daa0f82e55_cx1_cy7_cw97_w650_r1_s.jpg\")
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