Biogen investigating death linked to Aduhelm
The search for an effective treatment for the most common form of dementia, Alzheimer’s disease, has been long and hard in spite of the huge unmet need of the 55 million people currently living with the condition, a number that is expected to double every 20 years.
Yet, the arrival of a potential treatment, Biogen’s Aduhelm (aducanumab), has not perhaps been welcomed with the unalloyed joy some might have thought.
In addition to a controversial approval by the Food and Drug Administration (FDA) and slow uptake among physicians and patients, the drug has been plagued by reports about side effects.
The most worrying for many is amyloid-related imaging abnormalities – oedema (ARIA-E), an accumulation of the fluid in brain first seen in clinical trials for another human monoclonal antibody tested as a treatment for Alzheimer’s, bapineuzumab.
Now, Biogen has announced that it is investigating a fatal case of ARIA-E in a 75-year-old man who was taking Aduhelm. According to the company, the cause of death, which was reported through the FDA’s Adverse Event Reporting System (FAERS), ‘remains under investigation’. It said it would ‘continue to work with the reporting physician as well as global regulators to further understand the case. Alzheimer’s disease is complex, and patients affected by this devastating disease often suffer from other serious medical conditions’.
Read more: https://www.pmlive.com/pharma_news/biogen_investigating_death_linked_to_aduhelm_1383333
Yet, the arrival of a potential treatment, Biogen’s Aduhelm (aducanumab), has not perhaps been welcomed with the unalloyed joy some might have thought.
In addition to a controversial approval by the Food and Drug Administration (FDA) and slow uptake among physicians and patients, the drug has been plagued by reports about side effects.
The most worrying for many is amyloid-related imaging abnormalities – oedema (ARIA-E), an accumulation of the fluid in brain first seen in clinical trials for another human monoclonal antibody tested as a treatment for Alzheimer’s, bapineuzumab.
Now, Biogen has announced that it is investigating a fatal case of ARIA-E in a 75-year-old man who was taking Aduhelm. According to the company, the cause of death, which was reported through the FDA’s Adverse Event Reporting System (FAERS), ‘remains under investigation’. It said it would ‘continue to work with the reporting physician as well as global regulators to further understand the case. Alzheimer’s disease is complex, and patients affected by this devastating disease often suffer from other serious medical conditions’.
Read more: https://www.pmlive.com/pharma_news/biogen_investigating_death_linked_to_aduhelm_1383333
