{"id":5502,"date":"2021-07-09T15:52:49","date_gmt":"2021-07-09T07:52:49","guid":{"rendered":"https:\/\/www.9-design.net\/?p=5502"},"modified":"2021-07-09T15:52:49","modified_gmt":"2021-07-09T07:52:49","slug":"fda-approves-updated-aduhelm-prescribing-information-to-emphasize-population-studied-in-clinical-trials-aduhelm-should-be-initiated-in-patients-with-mild-cognitive-impairment-due-to-alzheim","status":"publish","type":"post","link":"https:\/\/www.9-design.net\/en\/2021\/07\/09\/fda-approves-updated-aduhelm-prescribing-information-to-emphasize-population-studied-in-clinical-trials-aduhelm-should-be-initiated-in-patients-with-mild-cognitive-impairment-due-to-alzheim\/","title":{"rendered":"FDA Approves Updated ADUHELM\u2122 Prescribing Information to Emphasize Population Studied in Clinical Trials   ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer\u2019s disease or mild Alzheimer\u2019s dementia"},"content":{"rendered":"<p><span id=\"page137R_mcid5\" class=\"markedContent\"><span dir=\"ltr\">CAMBRIDGE, Mass. and TOKYO, <\/span><span dir=\"ltr\">JU<\/span><span dir=\"ltr\">LY <\/span><span dir=\"ltr\">8<\/span><span dir=\"ltr\">,<\/span><span dir=\"ltr\">202<\/span><span dir=\"ltr\">1<\/span><span dir=\"ltr\">(GLOBE NEWSWIRE) <\/span><span dir=\"ltr\">\u2013 Biogen (Nasdaq: BIIB) and Eisai <\/span><span dir=\"ltr\">Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved <\/span><span dir=\"ltr\">an updated label<\/span><span dir=\"ltr\"> for ADUHELM\u2122 (aducanumab<\/span><span dir=\"ltr\">-avwa)<\/span><span dir=\"ltr\"> injection 100 mg\/mL solution. <\/span><\/span><\/p>\n<p><span id=\"page137R_mcid6\" class=\"markedContent\"><\/span><span id=\"page137R_mcid7\" class=\"markedContent\"><span dir=\"ltr\">The update includes<\/span><span dir=\"ltr\"> an addition to the <\/span><span dir=\"ltr\">Indications and Usage section<\/span><span dir=\"ltr\"> of the label<\/span><span dir=\"ltr\"> (Section 1)<\/span><span dir=\"ltr\"> to <\/span><span dir=\"ltr\">emphasize <\/span><span dir=\"ltr\">the <\/span><span dir=\"ltr\">disease stage<\/span><span dir=\"ltr\">s studied<\/span><span dir=\"ltr\"> in the clinical trials<\/span><span dir=\"ltr\">, as seen below<\/span><span dir=\"ltr\"> (<\/span><span dir=\"ltr\">italics<\/span><span dir=\"ltr\"> to note updated <\/span><span dir=\"ltr\">language)<\/span><span dir=\"ltr\">. <\/span><\/span><\/p>\n<p><span id=\"page137R_mcid8\" class=\"markedContent\"><\/span><em><span id=\"page137R_mcid9\" class=\"markedContent\"><span dir=\"ltr\">ADUHELM is indicated for the treatment of Alzheimer\u2019s disease. <\/span><span dir=\"ltr\">Treatment with <\/span><span dir=\"ltr\">ADUHELM should be initiated in patients with mild cognitive impairment or mild <\/span><span dir=\"ltr\">dementia stage of disease, the population in which treatment was init<\/span><span dir=\"ltr\">iated in clinical <\/span><span dir=\"ltr\">trials.<\/span><span dir=\"ltr\">There are no safety or effectiveness data on initiating treatment at earlier or <\/span><span dir=\"ltr\">later stages of the disease than were studied. <\/span><span dir=\"ltr\">This indication is approved under <\/span><span dir=\"ltr\">accelerated approval based on reduction in amyloid beta plaques obser<\/span><span dir=\"ltr\">ved in patients <\/span><span dir=\"ltr\">treated with ADUHELM. Continued approval for this indication may be contingent upon <\/span><span dir=\"ltr\">verification of clinical benefit in confirmatory trial(s).<\/span><\/span><\/em><\/p>\n<p><span id=\"page137R_mcid10\" class=\"markedContent\"><\/span><span id=\"page137R_mcid11\" class=\"markedContent\"><span dir=\"ltr\">Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, \u201cBased on o<\/span><span dir=\"ltr\">ur <\/span><span dir=\"ltr\">ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label <\/span><span dir=\"ltr\">update with the goal to further clarify the patient population that <\/span><span dir=\"ltr\">was<\/span><span dir=\"ltr\"> studied across the three <\/span><span dir=\"ltr\">ADUHELM clinical trials <\/span><span dir=\"ltr\">that<\/span><span dir=\"ltr\"> supported approval. We <\/span><span dir=\"ltr\">are committed to continue to listen to the <\/span><span dir=\"ltr\">community\u2019s needs as clinical practice adapts to this important, first<\/span><span dir=\"ltr\">-in<\/span><span dir=\"ltr\">-class treatment option.\u201d<\/span><\/span><\/p>\n<p><span id=\"page137R_mcid12\" class=\"markedContent\"><\/span><span id=\"page137R_mcid13\" class=\"markedContent\"><span dir=\"ltr\">The update clarifies the indication by emphasizing information about the disease stages studied in the <\/span><span dir=\"ltr\">ADUHELM <\/span><span dir=\"ltr\">clinical trials. Information about the population studied has been previously<\/span><span dir=\"ltr\"> communicated <\/span><span dir=\"ltr\">by Biogen<\/span><span dir=\"ltr\"> and Eisai<\/span><span dir=\"ltr\">, including in the compan<\/span><span dir=\"ltr\">ies\u2019<\/span><\/span><span id=\"page137R_mcid14\" class=\"markedContent\"><span dir=\"ltr\">statement<\/span><\/span><span id=\"page137R_mcid15\" class=\"markedContent\"><span dir=\"ltr\"> of June 23, 2021.<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CAMBRIDGE, Mass. and TOKYO, JULY 8,2021(GLOBE NEWSWIRE) \u2013 Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM\u2122 (aducanumab-avwa) injection 100 mg\/mL solution.<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"_links":{"self":[{"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/posts\/5502"}],"collection":[{"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/comments?post=5502"}],"version-history":[{"count":2,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/posts\/5502\/revisions"}],"predecessor-version":[{"id":5504,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/posts\/5502\/revisions\/5504"}],"wp:attachment":[{"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/media?parent=5502"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/categories?post=5502"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.9-design.net\/wp-json\/wp\/v2\/tags?post=5502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<a href="http://www.9-design.net/">久久人人97超碰超国产,天天摸夜夜添夜夜无码,久久精品人人槡人妻人人玩,97碰碰碰人妻无码视频</a>
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