FDA Speeds Approval on Alzheimer’s Drugs


Researchers are continually looking for effective drug treatments for Alzheimer’s patients, but they often face significant challenges in getting them approved by the Food and Drug Administration (FDA). However, the agency recently announced it will be changing its guidelines to ease the approval process and potentially change the face of Alzheimer’s care, The New York Times reports.

The FDA says it will now approve drugs even if they show just small improvements to memory and cognitive function in the earliest stages of the disease. This is a shift compared to the last decade because previously medication had to show substantial changes over a long period of time as well as improve activities of daily living. Experts say the change in policy could have a significant impact on the early stages of the condition.

“This is really a huge advance,” Dr. Eric Siemers, senior medical director for the Alzheimer’s disease team at Eli Lilly & Company, told the Times. “Kudos to the FDA.”

An estimated 5.4 million people in the United States have Alzheimer’s disease, and experts estimate that the number could triple by 2050. Approving more drugs, even if they only help in the earliest stages, could have a substantial impact.