{"id":6251,"date":"2019-10-23T17:59:47","date_gmt":"2019-10-23T12:29:47","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=6251"},"modified":"2025-05-08T12:03:28","modified_gmt":"2025-05-08T06:33:28","slug":"biogen-seeks-the-fda-approval-to-revive-its-alzheimers-drug-aducanumab","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/biogen-seeks-the-fda-approval-to-revive-its-alzheimers-drug-aducanumab","title":{"rendered":"Biogen seeks the FDA approval to revive its Alzheimer\u2019s drug Aducanumab"},"content":{"rendered":"\n

Not a long time ago this year, Biogen announced the halting of Phase III clinical trials, EMERGE and ENAGE, of its most looked upon drug aducanumab under simulations for the treatment of Alzheimer’s disease<\/a> called futility analysis. <\/p>\n\n\n\n

The drug was designed to help patients struggling with mild cognitive impairment and mild dementia<\/a> due to Alzheimer\u2019s disease. The failure of the trials to produce positive results and failure to meet the primary end-point led the Biogen and Eisai to decide on halting the further analysis of aducanumab. <\/p>\n\n\n\n

Shockingly enough, Biogen has revived the hopes\nof several patients by announcing the resurrection of its long-lost drug. The\ncompany is planning to submit marketing approval aducanumab of to the US FDA\nquoting that initial review was not in the lines of the data studied for more\npatients. <\/p>\n\n\n\n

The decision came after the successful conduct of Phase III EMERGE study which showed positive results in controlling the disease when the subjects took a relatively higher dose of aducanumab supporting the outcomes from the EMERGE.<\/p>\n\n\n\n

However, there still lies a hurdle. The FDA demands two successful trials for this drug and the company only has EMERGE<\/strong> to support its case. <\/p>\n\n\n\n

Alzheimer is a complex, degenerative disorder of the central nervous system affecting around 5.8 million people of age 65 and older. The onset of the disease starts way before the onset of its symptoms. Due to the non-availability of a standard diagnosis test, the determination of the exact cause of the disease becomes almost impossible. <\/p>\n\n\n\n

As per a survey by the U.S. Census Bureau, the Alzheimer’s disease prevalence<\/a> is going to increase as the American demography is going to shift from the fertile population to the older one, from 55 million in 2019 to 88 million by the year 2050. <\/p>\n\n\n\n

Alzheimer\u2019s therapy market is one of the toughest markets to survive in. Where several candidates failed, and many companies gave up, Biogen\u2019s move to bring the drug back in the competition is a brave move. However, the future of aducanumab is still in dark, and the assurance of the success is still uncertain. <\/p>\n\n\n\n

There exist companies that are running the\ntrials to dominate the Alzheimer\u2019s disease therapy market, as the field remains\nuntouched. Some of the key players in the therapeutic market of Alzheimer\u2019s\nDisease (AD) at a global level are Neurotrope bioscience, AgeneBio, Novartis,\nCortexyme, Eisai, TauRx Therapeutics, Otsuka Pharmaceutical, Genentech, MGC\nPharmaceuticals, Alkahest, AZ Therapies and others. Some have recently eneterd\nthe market while others have spent years in finidng a standard efficient cure\nto treat Alzheimer\u2019s disease. <\/p>\n\n\n\n

Alzheimer\u2019s disease pipeline include Bryostatin-1\n(Neurotrope Bioscience), AGB101 (AgeneBio), CAD106 and CNP520 (Novartis),\nCOR388 HCL (Cortexyme) E2609 or Elenbecestat (Eisai), TRx0237 (TauRx\nTherapeutics), brexpiprazole (Otsuka Pharmaceutical), RO7105705 (Genentech),\nAKST\/GRF6019 (Alkahest), ALZT-OP1 (AZ Therapies) and several others, which are\nstill in different phases of the clinical trials. <\/p>\n","protected":false},"excerpt":{"rendered":"

Not a long time ago this year, Biogen announced the halting of Phase III clinical trials, EMERGE and ENAGE, of its most looked upon drug aducanumab under simulations for the treatment of Alzheimer’s disease called futility analysis. The drug was designed to help patients struggling with mild cognitive impairment and mild dementia due to Alzheimer\u2019s […]<\/p>\n","protected":false},"author":1,"featured_media":6252,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[41],"tags":[2998,6641,72,830,1158],"industry":[17225],"therapeutic_areas":[17229],"class_list":["post-6251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-snippets","tag-aducanumab","tag-alzheimers-disease-therapies","tag-alzheimers-disease","tag-biogen","tag-dementia","industry-pharmaceutical","therapeutic_areas-central-nervous-system"],"acf":[],"yoast_head":"\nBiogen Seeks for FDA 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