"On 25 July, the European Medicines Agency (EMA) refused to approve the clinical use of lecanemab, a drug that can slow cognitive decline during the early stages of Alzheimer's disease...The decision puts the EMA at odds with regulatory bodies across the world."
"About 3.5% of those who take lecanemab experience adverse effects such as headaches or dizziness, caused by swelling or bleeding in the brain...US clinicians say that brain bleeds and swelling, which can be detected using magnetic resonance imaging (MRI), and other side effects are mostly manageable and less common than they had feared."
"I think that the EMA has overestimated the risks of lecanemab and underestimated - or misunderstood - the benefits...the drug can buy a person invaluable months or years to spend with loved ones before dementia sets in."
"I worry that the EMA's decision might reflect a broader emerging problem with the agency's assessments of medicines...I was excluded after disclosing that my research..."
Collection
[
|
...
]