{"id":20740,"date":"2023-06-10T00:13:42","date_gmt":"2023-06-10T04:13:42","guid":{"rendered":"https:\/\/ifintechworld.com\/investing\/fda-advisers-vote-in-favor-of-biogen-and-eisais-collaborative-alzheimers-treatment\/"},"modified":"2023-06-10T00:13:44","modified_gmt":"2023-06-10T04:13:44","slug":"fda-advisers-vote-in-favor-of-biogen-and-eisais-collaborative-alzheimers-treatment","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=20740","title":{"rendered":"FDA advisers vote in favor of Biogen and Eisai\u2019s collaborative Alzheimer\u2019s treatment"},"content":{"rendered":"
\n

Advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of the Eisai Co. Ltd. and Biogen Alzheimer\u2019s treatment Leqembi, saying that a clinical study had verified its benefit. <\/p>\n

Eisai
\n ESALF,
\n +9.35%<\/bg-quote>
\n shares jumped on the news and finished the day up 9.4%. Biogen
\n BIIB,
\n +1.31%<\/bg-quote>
\n stock trading was halted Friday during the advisory committee meeting. <\/p>\n

\n

Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a hallmark of Alzheimer\u2019s disease.\u00a0<\/p>\n

The treatment in January got a green light under the FDA\u2019s accelerated approval program, which allows for earlier approval of drugs that treat serious conditions even while studies to confirm the anticipated clinical benefit are ongoing. If those trials show that the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. An FDA decision on traditional approval is expected by July 6. Advisory committee votes are not binding, but the FDA often follows committee recommendations. <\/p>\n

About 6.7 million people 65 and older in the U.S. are living with Alzheimer\u2019s dementia, according to the Alzheimer\u2019s Association. Alzheimer\u2019s was the fifth-leading cause of death among people 65 and older in 2019, according to the association.\u00a0<\/p>\n

Traditional approval of Leqembi, which has a sticker price of $26,500 per year, could have a significant impact on Medicare spending. If Leqembi and similar new Alzheimer\u2019s treatments are granted traditional approval, the Centers for Medicare and Medicaid Services said last week that Medicare would cover the treatments in cases where the beneficiary\u2019s doctor and clinical team participate in collecting real-world evidence about how the drugs are working \u2014 a system known as a registry.\u00a0<\/p>\n

If 5% of the older adults with Alzheimer\u2019s disease take Leqembi, annual Medicare Part B spending would jump by about $8.9 billion, according to a recent analysis by health policy nonprofit KFF. The increased spending would likely lead to higher Part B premiums, according to the analysis. <\/p>\n

During the open public hearing portion of the FDA meeting Friday, several experts raised concerns that the difference in cognitive outcomes for patients treated with Leqembi seemed small and emphasized safety issues identified in the clinical trials, including potential brain swelling or bleeding. \u201cPatients and their families deserve better than false hope,\u201d Patricia Bencivenga, special projects coordinator for PharmedOut, a research and education project at Georgetown University Medical Center, told the committee. <\/p>\n

Other public commenters emphasized the value of any slowing in Alzheimer\u2019s patients\u2019 decline. \u201cThe additional time provided by these treatments is clear,\u201d Joanne Pike, president and CEO of the Alzheimer\u2019s Association, told the committee. \u201cThe value of this time is also clear when you listen directly to those who would benefit.\u201d <\/p>\n<\/p><\/div>\n<\/div>\n

Read the full article here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of the Eisai Co. Ltd. and Biogen Alzheimer\u2019s treatment Leqembi, saying that a clinical study had verified its benefit. Eisai ESALF, +9.35% shares jumped on the news and finished the day up 9.4%. Biogen BIIB, +1.31% stock trading was halted Friday […]<\/p>\n","protected":false},"author":1,"featured_media":20741,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[239],"tags":[83],"class_list":["post-20740","post","type-post","status-publish","format-video","has-post-thumbnail","hentry","category-investing","tag-featured","post_format-post-format-video"],"yoast_head":"\nFDA advisers vote in favor of Biogen and Eisai\u2019s collaborative Alzheimer\u2019s treatment | iFintechWorld<\/title>\n<meta name=\"description\" content=\"Advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of the Eisai Co. 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