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BLOG # 144

BLOG # 144

BLOG # 144

Biogen Alzheimer’s Drug Shows Brain Swelling in 35% of Patients

Biogen Inc.’s controversial Alzheimer’s drug Aduhelm produced brain swelling in 35% of patients who took the approved dose, although most didn’t experience symptoms, company researchers said in a study.

The study in JAMA Neurology found that 362 of 1,029 patients who received the approved dose of the drug experienced the side effect, which showed up in brain imaging of people in two big clinical trials of the drug. While most cases weren’t accompanied by symptoms, 94 patients experienced headache, confusion, dizziness or other effects.

Researchers are trying to understand the potential implications of the side effects — called amyloid-related imaging abnormalities, or ARIA — now that the drug is on the market and may be used in a wider group of patients than the carefully run clinical trials. Concerns have also risen since a patient with signs of ARIA reportedly died, although there’s no proven link between the side effect and the death.

Approved by the U.S. Food and Drug Administration in June, Aduhelm is controversial because the two large trials produced contradictory results as to whether it slows Alzheimer’s cognitive decline. Some of FDA’s scientific advisers resigned in protest after the approval, which was based on the drug’s ability to remove an Alzheimer’s-linked protein called amyloid from the brain.

commentary
opinion
The government’s agency to protect the public from drugs that are harmful, or just don’t work, has failed people with Alzheimer’s Disease.
La agencia del gobierno para proteger al público de los medicamentos que son dañinos, o simplemente no funcionan, le ha fallado a las personas con la enfermedad de Alzheimer.