Alzheimer's drug gets FDA panel's backing, setting the stage for broader use

[Omaha Steve]

Source: AP

By MATTHEW PERRONE today

WASHINGTON (AP) — Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.

The drug, Leqembi, received conditional approval from the Food and Drug Administration in January based on early results suggesting it could slow Alzheimer’s progression by several months. The FDA now is reviewing more definitive results to decide whether the drug should receive the agency’s full endorsement.

The decision carries extra significance because insurers have held off on paying for the infused treatment until it has full FDA approval.

The FDA panel of outside advisers voted 6-0 that a large company study confirmed the drug’s benefits for patients with mild or early Alzheimer’s. The nonbinding vote amounts to a recommendation for full approval, and the FDA is scheduled to issue a final decision on the matter by July 6.




Read more: https://apnews.com/article/leqembi-alzheimers-drug-fda-f438cd0d1df98d1df0677a219cee6fa7

[jmbar2]

1. Good news, with caveats...

Leqembi is the first drug that’s been convincingly shown to slow Alzheimer’s by targeting the underlying biology of the disease. The delay in progression amounts to about five months..

The drug was also associated with potentially serious side effects, including swelling of the brain and small bleeds in brain vessels.

Estimated cost $26,000 year, which could potentially drive up Medicare costs significantly due to the number of seniors with the disease. Hopefully the government can do something to drive down these costs.

Not a huge leap, but every step forward offers hope.

[leighbythesea2]

2. Anecdotally

I had a long conversation with someone whose father was in a trial for this drug, and got the drug they found out after. He had nearly zero decline in the 4 years. He was able to keep taking it after the trial, once it was revealed he had not been in placebo group. It was so encouraging to talk to her, bc my mom has Alzheimer’s. She’s past early stage, so could not take it now. But it’s heartening.

[SunSeeker]

3. Wow, that's great news!

I hope they can bring the price down.

[SouthernDem4ever]

4. Did they test it on trump?

How will we know if it really works?