2002, Food and Drug Administration, Leads and Side effects

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2002

Food and Drug Administration

Leads

Side effects

Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

Food and Drug Administration

Food and Drug Administration Medicine FDA Marketing

Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

Food and Drug Administration

Food and Drug Administration Safety Patients Leads

Pharma Rep Focus

Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

Paving the way for anti-Abeta active immunotherapy

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