The US Food and Drug Administration (FDA) has changed the registration status of the drug lecanemab-irmb from accelerated approval to traditional approval. This was made possible by positive results from the Phase III 301 randomized controlled clinical trial (CLARITY AD).
Lecanemab-irmb is designed to treat patients with Alzheimer's disease. It works by reducing amyloid plaques in the brain, which are a characteristic pathophysiological feature of the disease.
Lecanemab-irmb was first approved in the U.S. in January 2023 under an accelerated approval process. This pathway allows the FDA to approve drugs for serious conditions for which there is no trea...
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