Personal characteristics

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First NameFirst NameLast NameLast NameEmailEnter your email addressPhone NumberPhone Number Close this module RESERVE NOWSecure your spot in line for your custom Tesla. First NameFirst NameLast NameLast NameEmailEnter your email addressPhone NumberPhone Number. Aducanumab (Aduhelm) was recently approved by the US Food and Drug Administration (FDA) for the treatment of Alzheimer disease (AD).

The approval of aducanumab is controversial. We address why we support this decision and welcome the availability of personal characteristics as an important therapy for patients with early AD.

Building on a phase 1B study that informed dose decisions and demonstrated amyloid lowering by aducanumab, Biogen launched 2 phase 3 trials: EMERGE personal characteristics ENGAGE. At trial initiation, participants were randomized to high dose, low dose, or placebo. Amyloid lowering was robust and statistically significant in both dose groups.

CSF biomarker analyses revealed significant dose-related reductions personal characteristics hyperphosphorylated tau in the active treatment groups.

Pooled EMERGE and ENGAGE data for tau PET showed increases in the placebo group and less increase or decreases in the high-dose group in several cortical regions. There was significant amyloid lowering in both dose arms. The FDA approved personal characteristics using the accelerated approval pathway that allows personal characteristics of a drug based on a biomarker considered reasonably likely to predict clinical benefit.

Accelerated approval is accompanied by a requirement to generate additional efficacy and safety data in personal characteristics postmarketing study.

The biomarker considered likely to predict clinical benefit was plaque lowering demonstrated by amyloid PET. The body of evidence supporting use of aducanumab in patients with early AD includes consistent amyloid reduction on PET imaging, personal characteristics of decline on primary and secondary outcome measures schering bayer ag EMERGE, encouraging effects on biomarkers consistent with effect on biological processes linked to disease progression, and preliminary observations of slowing of cognitive decline in other trials of plaque-lowering antibodies (e.

The absence of disease-modifying therapies for AD supports making the therapy available on the basis of these data. Further study is required to confirm clinical benefits and to identify individuals most likely personal characteristics respond. Successful personal characteristics of aducanumab will require collaboration among primary care clinicians and specialists and a commitment to equity of personal characteristics. Aducanumab opens personal characteristics new era in AD research and care and provides a foundation for development of progressively better therapies.

Salloway was a site PI and personal characteristics of the investigator steering committee for the ENGAGE trial and receives research support and consultancy fees from Biogen, Eisai, Lilly, Avid, Genentech, and Roche.

Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. Draw All authors' disclosures must be entered and current in our database before comments can be posted.

Exception: replies to comments concerning an article you originally authored do not require updated disclosures. Study FundingThe authors report no targeted funding. Appendix AuthorsFootnotesGo to Neurology. Editorial, page 517See page 545References1. Combined FDA and applicant PCNS Drugs Advisory Committee briefing document.

Accessed July 4, 2021. Guidelines for the personal characteristics evaluation of antidementia drugs.

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