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LETTER FROM EDITOR

Aducanumab issue

ADUCANUMAB APPROVAL

Surrogate endpoint

PAYER VIEW

Reimbursement debate

BIOTECH VIEW

Alzheimer's inflection

INVESTOR VIEW

Recalibrating risk

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Lilly, Roche

EDITOR'S COMMENT

Eroding public trust

ACCELERATED APPROVALS

By disease, time

0607 Adu ALERT
BioCentury & Getty Images

Product Development

β-amyloid becomes surrogate endpoint for Alzheimer’s, despite no clear link to cognitive outcomes

FDA’s decision to approve Biogen’s aducanumab could bring new therapies to patients faster 

FDA’s decision to approve Biogen’s aducanumab could bring other new treatments to patients faster, but the benefit of those treatments could be uncertain.

Jun 7, 2021 | 9:11 PM GMT

FDA’s accelerated approval of aducanumab marks the acceptance of β-amyloid as a surrogate endpoint for Alzheimer’s disease, despite no prior clinical evidence linking the biomarker to cognitive outcomes. The move opens the door to other companies expediting development, and raises the specter that a glut of therapies with unknown clinical benefit could soon enter the market.

FDA planted itself squarely on the side of the amyloid hypothesis in its Monday

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