{"id":1663,"date":"2024-03-08T10:45:07","date_gmt":"2024-03-08T11:45:07","guid":{"rendered":"https:\/\/medexperts.pro\/?p=1663"},"modified":"2024-03-12T21:03:42","modified_gmt":"2024-03-12T21:03:42","slug":"f-d-a-delays-action-on-closely-watched-alzheimers-drug","status":"publish","type":"post","link":"https:\/\/medexperts.pro\/?p=1663","title":{"rendered":"F.D.A. Delays Action on Closely Watched Alzheimer\u2019s Drug"},"content":{"rendered":"
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Eli Lilly\u2019s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug\u2019s safety and efficacy.<\/p>\n

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The Food and Drug Administration has decided to delay action on a closely watched Alzheimer\u2019s drug, donanemab, which the agency was widely expected to approve this month. The F.D.A. will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug\u2019s maker, Eli Lilly and Company, said Friday.<\/p>\n

\u201cThe F.D.A. has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,\u201d the company said in a statement.<\/p>\n

The decision is likely to surprise many Alzheimer\u2019s experts, doctors and patients who had expected the medication would soon be on the market. The F.D.A.\u2019s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year.<\/p>\n

\u201cWe were not expecting this,\u201d Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview. She said that while the F.D.A. often calls on such independent advisory committees when it has questions about drugs, it was unusual to do so \u201cat the end of the review cycle and beyond the action date that the F.D.A. had given us.\u201d<\/p>\n<\/div>\n<\/div>\n

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The F.D.A. did not say anything publicly about the move, which will delay any decision about whether to approve donanemab until at least later this year. Lilly officials said they expected it would be a few months before the advisory committee holds a hearing.<\/p>\n

\u201cThe F.D.A. did commit to us to move quickly, so we would hope that they would then take action shortly after the advisory committee,\u201d Mrs. White said.<\/p>\n

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Eli Lilly\u2019s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug\u2019s safety and efficacy.The Food and Drug Administration has decided to delay action on a closely watched Alzheimer\u2019s drug, donanemab, which the agency was widely expected to approve this month. The F.D.A. will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug\u2019s maker, Eli Lilly and Company, said Friday.\u201cThe F.D.A. has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,\u201d the company said in a statement.The decision is likely to surprise many Alzheimer\u2019s experts, doctors and patients who had expected the medication would soon be on the market. The F.D.A.\u2019s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year.\u201cWe were not expecting this,\u201d Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview. She said that while the F.D.A. often calls on such independent advisory committees when it has questions about drugs, it was unusual to do so \u201cat the end of the review cycle and beyond the action date that the F.D.A. had given us.\u201dThe F.D.A. did not say anything publicly about the move, which will delay any decision about whether to approve donanemab until at least later this year. Lilly officials said they expected it would be a few months before the advisory committee holds a hearing.\u201cThe F.D.A. did commit to us to move quickly, so we would hope that they would then take action shortly after the advisory committee,\u201d Mrs. White said.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and\u00a0log into\u00a0your Times account, or\u00a0subscribe\u00a0for all of The Times.Thank you for your patience while we verify access.Already a subscriber?\u00a0Log in.Want all of The Times?\u00a0Subscribe.<\/p>\n","protected":false},"author":1,"featured_media":1665,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[],"class_list":["post-1663","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1663","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1663"}],"version-history":[{"count":2,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1663\/revisions"}],"predecessor-version":[{"id":1666,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1663\/revisions\/1666"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/media\/1665"}],"wp:attachment":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1663"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1663"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}