MADISON, Wis. — The FDA granted full approval for a new anti-amyloid drug to treat Alzheimer's disease.

It targets and removes amyloid plaque buildup in the brain and is one of the first dementia drugs that appears to slow the progression of cognitive decline.

What You Need To Know

  • FDA gives full approval for new Alzheimer's treatment

  • That move means broader coverage of the drug by Medicare

  • UW Health, the VA system and other health systems around the country are working to make sure everything's in place to give patients access to the therapy and make sure they are well monitored

  • Patients should discuss with their clinicians whether the drug's benefits outweigh the risks 

Lecanemab, sold under the brand name Leqembi, was conditionally approved by the FDA back in January, but Medicare did not widely cover it. With this full approval the federal Centers for Medicare & Medicaid Services will provide broader coverage which should give eligible patients more access to the treatment.

Dr. Cindy Carlsson, director of the Wisconsin Alzheimer's Institute at the the University of Wisconsin School of Medicine and Public Health, called this an exciting move for research and clinical care.

One requirement for Medicare coverage is recipients of the drug enroll in a registry that tracks safety and effectiveness.

"It will be part of a system that will help to gather more information about who is best to receive this therapy, what are the side effects, how can we tailor our monitoring to make sure people are given the drug in a way that's safe," Carlsson explained. 

The drug is approved only for people with mild cognitive impairment or mild dementia who have been confirmed to have amyloid plaques in their brains.

Watch the full interview with Carlsson above. 

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