FDA approves Biogen's Alzheimer's drug, the first new medicine for the disease in 18 years

FDA approves Biogen's Alzheimer's drug, the first new medicine for the disease in 18 years

Publication date: Jun 08, 2021

If aducanumab were approved, critics contended, it would have made it hard to recruit Alzheimer’s patients for clinical trials for other drugs where some volunteers would get a placebo. -Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003,” Dr. Patricia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement. Nonetheless, Biogen concluded that aducanumab slowed cognitive decline and that the key to effectiveness was giving patients a high enough dose. Those drugs typically delay the decline for several months, and none address the underlying causes of the disease, as aducanumab is meant to do. The ruling is certain to be cheered by Alzheimer’s patients, their families, and advocates who have hungered for a drug more effective than the five previously approved. Patients are expected to receive the drug intravenously for about an hour every four weeks, unlike older drugs like Namenda and Aricept, which come in pill form. Aducanumab is a monoclonal antibody made from the immune cells of older people with no or uncommonly slow cognitive decline.

Concepts Keywords
Alzheimers Earlier stages disease
Amyloid Pathophysiology Alzheimers disease
Biotech Illness
Fda Diseases
Massachusetts Complex Alzheimers disease
Medicine Members disease
Mondays Health sciences
Life sciences
Monoclonal antibodies
Amyloidosis
Aducanumab
Spinal muscular atrophy
Biogen
Alzheimer’s disease
Drug discovery
Amyloid beta
Clinical trial
MRI

Semantics

Type Source Name
disease MESH cause of death
disease MESH neurological disorders
disease MESH multiple sclerosis
disease MESH brain swelling
disease MESH confusion
disease MESH cognitive decline
disease MESH amyloid plaques
disease MESH development
disease MESH Memory Disorders
drug DRUGBANK Aducanumab
drug DRUGBANK Iron

Original Article

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