FDA approves ‘robust’ dementia drug that slows cognitive decline

[Kamaji]

FDA approves ‘robust’ dementia drug that slows cognitive decline

By Marc Lallanilla
June 12, 2023

A Food and Drug Administration panel has unanimously approved the use of lecanemab to slow the progression of Alzheimer’s disease.

The expert panel described the results of a clinical trial of lecanemab as “robust” and “clear and consistent,” according to Medscape.

Their approval means the medication, which is sold under the brand name Leqembi, should get full FDA approval by July 6, giving hope to the 6.5 million people affected by Alzheimer’s disease, a brain disorder that gets worse over time.

But even though the FDA approved lecanemab through an accelerated approval process, the Centers for Medicare and Medicaid Services — which controls Medicare — will only cover the drug for patients who enroll in a national registry.

That registry does not yet exist, and it’s still unknown when or how patients, their doctors or caregivers would sign up for it.

*  *  *

Source:  https://nypost.com/2023/06/12/fda-approves-dementia-drug-that-slows-cognitive-decline/

[mountaineer]

Too late for el presidente, I'd wager.

[Wingnut]

Clinical trials were conducted with o group of 100 including Joe Biden.  However records show, Biden was in the Placebo group.

[libertybele]

Patients have to enroll in a national registry in order to get the drug .... yet the article states that the national registry doesn't exist yet!   I wonder how long the gov't is going to take to construct a national registry???   

Why do patients have to go through a national registry????

[mountaineer]

  I wonder how long the gov't is going to take to construct a national registry???   

Come on, now. We know every single federal employee is all wrapped up in pride month right now. Then next month, they'll all go on vacation.

[corbe]

   Every drug that the FDA has yanked off the market was once approved by the FDA.  FACT

[GtHawk]

  Why would they need a national registry of dementia patients...maybe so they can target conservatives and have them declared not competent to vote or exercise some other right?

[libertybele]

Why would they need a national registry of dementia patients...maybe so they can target conservatives and have them declared not competent to vote or exercise some other right?

That is what I was wondering -- why do they have to go through a national registry??

[corbe]

   They already have that info with the advent of obumercare and the dismantling of the Patient/Dr privilege.

[berdie]

That is what I was wondering -- why do they have to go through a national registry??

It could be the users of this drug will actually be the true test group?

[libertybele]

It could be the users of this drug will actually be the true test group?

...hmm that could be a possibility too.  I'd be darn skeptical. I was thinking perhaps those registered would not be able to own a firearm.

[berdie]

...hmm that could be a possibility too.  I'd be darn skeptical. I was thinking perhaps those registered would not be able to own a firearm.

I hadn't thought of that...but  very possible.