Questions emerge as biogen claims aducanumab turnaround

Questions emerge as biogen claims aducanumab turnaround

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Trials of aducanumab in Alzheimer disease were previously discontinued following a phase III futility analysis, but Biogen now says that additional data indicate that longer exposure to the higher dose might be effective. The company is seeking FDA approval for the treatment; however, the limited data released do not establish efficacy. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution RELEVANT ARTICLES Open Access articles citing this article. * UNRAVELING ALZHEIMER’S: THE PROMISE OF ADUCANUMAB, LECANEMAB, AND DONANEMAB * Taha Basit Ameen * , Syeda Naveera Kashif *  … Abdul Raheem _The Egyptian Journal of Neurology, Psychiatry and Neurosurgery_ Open Access 14 June 2024 * A POSITIVE FEEDBACK INHIBITION OF ISOCITRATE DEHYDROGENASE 3Β ON PAIRED-BOX GENE 6 PROMOTES ALZHEIMER-LIKE PATHOLOGY * Xin Wang * , Qian Liu *  … Jian-Zhi Wang _Signal Transduction and Targeted Therapy_ Open Access 29 April 2024 * MITOCHONDRIAL HYPERMETABOLISM PRECEDES IMPAIRED AUTOPHAGY AND SYNAPTIC DISORGANIZATION IN APP KNOCK-IN ALZHEIMER MOUSE MODELS * Luana Naia * , Makoto Shimozawa *  … Per Nilsson _Molecular Psychiatry_ Open Access 01 November 2023 ACCESS OPTIONS Access through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Sevigny, J. et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. _Nature_ 537, 50–56 (2016). Article  CAS  Google Scholar  * Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s disease. investors.biogen.com http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials (2019). * Biogen. Biogen Q1 2019 Earnings Presentation. investors.bogen.com http://investors.biogen.com/static-files/1e8f9954-58d4-41cf-a6d7-6626338656c3 (2019). * Biogen. Biogen Q3 2019 Earnings Presentation. investors.biogen.com http://investors.biogen.com/static-files/40565136-b61f-4473-9e58-9be769bbac6c (2019). * Siemers, E. R. et al. Phase 3 solanezumab trials: secondary outcomes in mild Alzheimer’s disease patients. _Alzheimers Dement._ 12, 110–120 (2016). Article  Google Scholar  * Honig, L. S. et al. Trial of solanezumab for mild dementia due to Alzheimer’s disease. _N. Engl. J. Med._ 378, 321–330 (2018). Article  CAS  Google Scholar  * Thompson, B. Statistical significance, result importance, and result generalizability: three noteworthy but somewhat different issues. _Meas. Eval. Coun. Dev._ 22, 2–6 (1989). Article  Google Scholar  * Andrews, J. S. et al. Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer’s disease clinical trials. _Alzheimers Dement._ 5, 354–363 (2019). Google Scholar  * Strauss D. Biogen surges 42% after stunning reversal sees it revive plans for Alzheimer’s treatment (BIIB). Business Insider https://markets.businessinsider.com/news/stocks/biogen-stock-price-soars-on-plan-to-revive-alzheimers-treatment-2019-10-1028619410 (2019). Download references AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Division of Psychiatry, University College London, London, UK Robert Howard & Kathy Y. Liu Authors * Robert Howard View author publications You can also search for this author inPubMed Google Scholar * Kathy Y. Liu View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Robert Howard. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing interests. RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Howard, R., Liu, K.Y. Questions EMERGE as Biogen claims aducanumab turnaround. _Nat Rev Neurol_ 16, 63–64 (2020). https://doi.org/10.1038/s41582-019-0295-9 Download citation * Published: 29 November 2019 * Issue Date: February 2020 * DOI: https://doi.org/10.1038/s41582-019-0295-9 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative

Trials of aducanumab in Alzheimer disease were previously discontinued following a phase III futility analysis, but Biogen now says that additional data indicate that longer exposure to the 


higher dose might be effective. The company is seeking FDA approval for the treatment; however, the limited data released do not establish efficacy. Access through your institution Buy or


subscribe This is a preview of subscription content, access via your institution RELEVANT ARTICLES Open Access articles citing this article. * UNRAVELING ALZHEIMER’S: THE PROMISE OF


ADUCANUMAB, LECANEMAB, AND DONANEMAB * Taha Basit Ameen * , Syeda Naveera Kashif *  … Abdul Raheem _The Egyptian Journal of Neurology, Psychiatry and Neurosurgery_ Open Access 14 June 2024 *


A POSITIVE FEEDBACK INHIBITION OF ISOCITRATE DEHYDROGENASE 3Β ON PAIRED-BOX GENE 6 PROMOTES ALZHEIMER-LIKE PATHOLOGY * Xin Wang * , Qian Liu *  … Jian-Zhi Wang _Signal Transduction and


Targeted Therapy_ Open Access 29 April 2024 * MITOCHONDRIAL HYPERMETABOLISM PRECEDES IMPAIRED AUTOPHAGY AND SYNAPTIC DISORGANIZATION IN APP KNOCK-IN ALZHEIMER MOUSE MODELS * Luana Naia * ,


Makoto Shimozawa *  … Per Nilsson _Molecular Psychiatry_ Open Access 01 November 2023 ACCESS OPTIONS Access through your institution Access Nature and 54 other Nature Portfolio journals Get


Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and online access $209.00 per year only


$17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes which are calculated during checkout


ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Sevigny, J. et al. The antibody aducanumab reduces Aβ


plaques in Alzheimer’s disease. _Nature_ 537, 50–56 (2016). Article  CAS  Google Scholar  * Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s


disease. investors.biogen.com http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials (2019). * Biogen. Biogen Q1 2019


Earnings Presentation. investors.bogen.com http://investors.biogen.com/static-files/1e8f9954-58d4-41cf-a6d7-6626338656c3 (2019). * Biogen. Biogen Q3 2019 Earnings Presentation.


investors.biogen.com http://investors.biogen.com/static-files/40565136-b61f-4473-9e58-9be769bbac6c (2019). * Siemers, E. R. et al. Phase 3 solanezumab trials: secondary outcomes in mild


Alzheimer’s disease patients. _Alzheimers Dement._ 12, 110–120 (2016). Article  Google Scholar  * Honig, L. S. et al. Trial of solanezumab for mild dementia due to Alzheimer’s disease. _N.


Engl. J. Med._ 378, 321–330 (2018). Article  CAS  Google Scholar  * Thompson, B. Statistical significance, result importance, and result generalizability: three noteworthy but somewhat


different issues. _Meas. Eval. Coun. Dev._ 22, 2–6 (1989). Article  Google Scholar  * Andrews, J. S. et al. Disease severity and minimal clinically important differences in clinical outcome


assessments for Alzheimer’s disease clinical trials. _Alzheimers Dement._ 5, 354–363 (2019). Google Scholar  * Strauss D. Biogen surges 42% after stunning reversal sees it revive plans for


Alzheimer’s treatment (BIIB). Business Insider https://markets.businessinsider.com/news/stocks/biogen-stock-price-soars-on-plan-to-revive-alzheimers-treatment-2019-10-1028619410 (2019).


Download references AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Division of Psychiatry, University College London, London, UK Robert Howard & Kathy Y. Liu Authors * Robert Howard View


author publications You can also search for this author inPubMed Google Scholar * Kathy Y. Liu View author publications You can also search for this author inPubMed Google Scholar


CORRESPONDING AUTHOR Correspondence to Robert Howard. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing interests. RIGHTS AND PERMISSIONS Reprints and permissions


ABOUT THIS ARTICLE CITE THIS ARTICLE Howard, R., Liu, K.Y. Questions EMERGE as Biogen claims aducanumab turnaround. _Nat Rev Neurol_ 16, 63–64 (2020).


https://doi.org/10.1038/s41582-019-0295-9 Download citation * Published: 29 November 2019 * Issue Date: February 2020 * DOI: https://doi.org/10.1038/s41582-019-0295-9 SHARE THIS ARTICLE


Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided


by the Springer Nature SharedIt content-sharing initiative