FDA’s dilemma with the aducanumab approval: public pressure and hope, surrogate markers and efficacy, and possible next steps

Regulatory decisions diverge over aducanumab for Alzheimer’s disease

(2022) Mark P Lythgoe et al.   BMJ-British Medical Journal

Sutimlimab: First Approval

(2022) Sohita Dhillon   DRUGS

Donanemab in Early Alzheimer’s Disease

(2021) Mark A. Mintun et al.   NEW ENGLAND JOURNAL OF MEDICINE

Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental variable meta-analysis

(2021) Sarah F Ackley et al.   BMJ-British Medical Journal

Evaluation of Aducanumab for Alzheimer Disease

(2021) G. Caleb Alexander et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Bayes analysis supports null hypothesis of anti‐amyloid beta therapy in Alzheimer's disease

(2021) Edo Richard et al.   Alzheimers & Dementia

Critical Appraisal of Amyloid Lowering Agents in AD

(2021) Boris Decourt et al.   Current Neurology and Neuroscience Reports

Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment

(2021) Timothy S. Anderson et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Recently Approved Alzheimer Drug Raises Questions That Might Never Be Answered

(2021) Rita Rubin   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Landmark Alzheimer’s drug approval confounds research community

(2021) Asher Mullard   NATURE

Can we learn lessons from the FDA’s approval of aducanumab?

(2021) Kathy Y. Liu et al.   Nature Reviews Neurology

Controversy and Progress in Alzheimer’s Disease — FDA Approval of Aducanumab

(2021) Gil D. Rabinovici   NEW ENGLAND JOURNAL OF MEDICINE

FDA approves controversial Alzheimer’s drug despite uncertainty over effectiveness

(2021) Elisabeth Mahase   BMJ-British Medical Journal

FDA calls for investigation into industry influence during Alzheimer’s drug approval

(2021) Owen Dyer   BMJ-British Medical Journal

Approval of Aducanumab for Alzheimer Disease—the FDA’s Perspective

(2021) Billy Dunn et al.   JAMA Internal Medicine

US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?

(2021) Vincent Planche et al.   JAMA Neurology

What have we learned from past failures of investigational drugs for Alzheimer’s disease?

(2021) Bruno P. Imbimbo et al.   EXPERT OPINION ON INVESTIGATIONAL DRUGS

FDA Drug Approval and the Ethics of Desperation

(2021) Emily A. Largent et al.   JAMA Internal Medicine

What the Aducanumab Approval Reveals About Alzheimer Disease Research

(2021) Jennifer J. Manly et al.   JAMA Neurology

Aducanumab, gantenerumab, BAN2401, and ALZ-801—the first wave of amyloid-targeting drugs for Alzheimer’s disease with potential for near term approval

(2020) Martin Tolar et al.   Alzheimers Research & Therapy

Association of black race with recurrent stroke risk

(2016) Jong-Ho Park et al.   JOURNAL OF THE NEUROLOGICAL SCIENCES

The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease

(2016) Jeff Sevigny et al.   NATURE

Therapies for Prevention and Treatment of Alzheimer’s Disease

(2016) J. Mendiola-Precoma et al.   Biomed Research International

Post Hoc Analyses

(2015) Titte R. Srinivas et al.   TRANSPLANTATION

Blood Pressure and the Risk of Developing Diabetes in African Americans and Whites: ARIC, CARDIA, and the Framingham Heart Study

(2011) G. S. Wei et al.   DIABETES CARE

Why Do Black Americans Have Higher Prevalence of Hypertension?

(2011) Flávio D. Fuchs   HYPERTENSION

Coverage with Evidence Development: Applications and issues

(2010) Paul Trueman et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE