The FDA has granted accelerated approval to a second Alzheimer’s drug that trial data show offers modest benefits to patients.
The U.S. Food and Drug Administration building behind FDA logos at a bus stop in Silver Spring, Maryland, in August 2018. | AP Photo/Jacquelyn MartinOn Friday, the FDA granted accelerated approval to a second Alzheimer’s disease drug in the past two years that trial data show offers modest benefits to patients.
In clinical trials, Leqembi, formerly known as lecanemab, slowed the progressive cognitive decline associated with Alzheimer’s. It also reduced proteins that accumulate on the brain associated with the disease. The FDA did not call for an advisory committee meeting before approving Leqembi. An agency spokesperson said the drug is not the first in its class nor did its application raise any new or unexpected safety concerns.
“We will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” said CMS Administrator Chiquita Brooks-LaSure in a statement.
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