Unanimous Thumbs-Up From FDA Advisors for Alzheimer’s Drug

By Judy George, MedPage Today

An FDA advisory committee on Monday unanimously supported the investigational drug donanemab for treating early Alzheimer’s disease.

In an 11-0 vote, the Peripheral and Central Nervous System Drugs Advisory Committee said the benefits of donanemab outweighed its risks for the population of Alzheimer’s disease patients with mild cognitive impairment and mild dementia enrolled in the donanemab clinical trials.

The committee also voted 11-0 that available data showed that donanemab was effective in treating Alzheimer’s disease in that population. Though FDA staffers raised concerns last week that Alzheimer’s patients with no or very low tau were excluded from the pivotal donanemab trial, the committee agreed overall that the drug should not be restricted to Alzheimer’s patients with a specific tau burden. Read more…