FDA expected to make decision on controversial Alzheimer’s drug this week

The FDA are expected to come to a decision on Eisai and Biogen’s Alzheimer’s drug lecanemab by the end of the week. They are due to decide whether or not to grant the drug accelerated approval.

Results from a study last year showed that the drug slowed cognitive decline in patients in the early stages of Alzheimer’s Disease, which looked promising for the drug’s approval. However, there were multiple reports of serious adverse events in some trial patients, such as brain swelling and bleeding, which have triggered queries about the drug’s safety.

This drug has been one of the only experimental drugs to slow decline in patients with the disease, which offered a level of hope to the 6 million people with Alzheimer’s in the US alone. The two deaths of patients in the trial have made its potential approval somewhat controversial, however Eisai have stated that the drug is not associated with “an increased risk of death overall or from any specific cause.”

An Eisai spokesperson commented: “If lecanemab is approved by the FDA under the Accelerated Approval Pathway, Eisai will do its best to make lecanemab available as soon as possible. Eisai aims to file a Supplemental Biologics License Application for traditional approval in the US soon and to file for marketing authorisation applications in Japan and Europe by the end of Eisai’s fiscal year 2022, which ends on March 31, 2023.”

Betsy Goodfellow