July 6, 2023 –
The drug was granted accelerated approval in January, which allows the FDA to approve drugs for conditions when there is a defined need. It is the first therapy for Alzheimer’s granted full agency approval in 20 years. The FDA said the drug"demonstrated a statistically significant and clinically meaningful" reduction in decline from the disease. There are risks of brain bleeding and swelling, which sometimes can be fatal, the agency said.
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