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FDA Fully Approves Leqembi, an Alzheimer Drug That Slows the Disease’s Progression

FDA Fully Approves Leqembi, an Alzheimer Drug That Slows the Disease’s Progression

The agency moved it to “traditional approval following a determination that a confirmatory trial verified clinical benefit.”

What wonderful news.

For the first time, the FDA fully approved a drug to treat Alzheimer’s, “which slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.”

Leqembi is a drug that can slow the progression of Alzheimer’s. The FDA conditionally approved the drug in January.

The agency moved it to “traditional approval following a determination that a confirmatory trial verified clinical benefit.”

Considering it’s a devastating disease, it doesn’t shock me that people asked to try the medicine during the testing period:

The Food and Drug Administration on Thursday granted full approval to Leqembi, allowing Medicare enrollees to get fully covered treatment with the drug if they qualify and agree to report data to a registry. Most of the six million people in the U.S. with Alzheimer’s are eligible for Medicare.

Eisai, which developed the drug with Biogen, said Leqembi could generate $7 billion in annual sales globally by 2030.

Clinics said they have been flooded with queries from patients eager to use Leqembi despite safety concerns. But adoption will be limited by shortages of doctors and specialty centers that are best equipped to prescribe the drug, neurologists said.

Leqembi, which the FDA conditionally approved in January but Medicare didn’t widely cover, is part of a class of Alzheimer’s drugs that target amyloid, a sticky plaque in the brain that some researchers think plays a role in driving the disease. It is the first anti-amyloid treatment the FDA has fully approved and the first to clearly slow cognitive decline in patients with early Alzheimer’s.

I’m not one who thinks a patient should have to wait for the FDA to approve a drug. I have rheumatoid arthritis, lupus, and Sjögren’s syndrome. If I could try a new medicine, I’d say, “Sign me up!”

Thank goodness Medicare will cover it. If you’re going to force people to use Medicare, then cover the dang medicine they could need.


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Biden says he has tested it and recommends it for other Alzheimers patients.

Actually, Medicare has been great so far, except for drug coverage

I use GoodRx 80% of time

    CommoChief in reply to gonzotx. | July 7, 2023 at 12:14 pm

    It works pretty well for patients until it doesn’t. Medicare part A (hospital) trust fund is exhausted in the next few years, estimates range from 2026 to 2028. At that point there will be about a 10% shortfall in payments to hospitals the first year. The shortfall will grow larger each year thereafter. Eventually some hospitals will rethink whether they can afford to continue accepting Medicare. It indirectly impacts Veterans and AD military because hospitals that accept Medicare must also accept Tricare. This combined with a substantial shift within DoD to push retirees and families to ‘off post’ medical care v using military facilities and mighty providers is gonna hurt.

    The other parts of Medicare are funded from premiums and transfer of money from general Federal revenue so drug coverage, Dr bills and things like physical therapy won’t be directly impacted by the Medicare trust fund becoming depleted. They may be indirectly impacted depending upon whatever consensus plan emerges to fix the overall Medicare system to make it sustainable going forward.

    jb4 in reply to gonzotx. | July 7, 2023 at 4:59 pm

    I use GoodRx for all meds except a thyroid med where Walmart mail order pharmacy in TX is best, under their $10 for 90 days program.

E Howard Hunt | July 7, 2023 at 11:45 am

I know a brilliant lady diagnosed with early onset Alzheimer’s at age 49. Now at age 50, she can’t read a clock or find her way home after a two-block stroll. We have all seen, during COVID, what whores the drug companies are. This drug probably has a third of the benefits claimed and ten times the side effects. But what sufferer wouldn’t take it? It is cause for modest celebration while the search for a truly effective treatment continues.

Just in time for the Democratic primaries.

The_Mew_Cat | July 7, 2023 at 12:12 pm

This drug is old news. I’m sure they are giving Biden their best stuff that is still in the lab phase.

Let me guess…
This important Medical Discovery is available for a Gazillion Dollars per pill.
BUT….If you order today…
We’ll send you this miracle med for the Low Low price of…
$9 99 99 99!!!!!!
You’ll feel like you’re in your 20’s again….
At the office. In the gym…AND….in the bedroom!

(may cause serious side effects….discontinue use if you experience brain cramping, hair growth on eye balls, uncontrollable flatulence and projectile diarrhea, club feet/loss of rhythm….)

nordic prince | July 7, 2023 at 1:59 pm

Sorry, but at this point, post-covid, I wouldn’t trust the FDA to tell me something as innocuous as water was safe.

Who do they hire to come up with these names?

Former President Donald Trump pushed back on a questioner’s skepticism about the effectiveness and safety of the Covid-19 vaccine in a new interview, saying that the “vaccine works” and “people aren’t dying when they take the vaccine.”

“Look, the results of the vaccine are very good, and if you do get (Covid), it’s a very minor form. People aren’t dying when they take the vaccine,”

— I believed Donald Trump. Not any more.

BierceAmbrose | July 7, 2023 at 7:38 pm

Permission is nice; why are they in that gatekeeping position these days?

How about all the info of the drug is indexed n published. With the extensive universal education we inflict these days, doubtles everyone can understand it just fine, and in less than the 73 years the Feds wanted to release the data supporting the ‘rona jab auth they issued in a couple months.

I’m not one who thinks a patient should have to wait for the FDA to approve a drug.

I think even drugs with known dangers should be acceptable with full disclosure. Remember Vioxx? It wasn’t like people were dropping dead like flies from heart attacks, and for many it was the only drug that effectively treated their intense pain. That problem is worsened by the FDA’s criminal prosecutions of doctors prescribing pain meds, and subsequent extreme timidity of doctors to treat pain. I’ve had IV morphine for kidney stones (before administration I was vomiting to the point of empty heaving from the pain) and I never felt high at all let alone had any desire to acquire a future supply of it. It sure felt good not to hurt anymore though. I would argue that only a minority of people are addiction-prone, and treating everyone as if they are does great disservice to patients.

This is the, I think, second monoclonal antibody drug for Alzheimer. The first causes lots of brain swelling. Leqembi will cost over $25,00o/year. It is indicated for mild dementia and makes a moderate decrease in decline from the disease. You don’t get better. There are lots of side effects. Respectfully, “’I’m not one who thinks a patient should have to wait for the FDA to approve a drug” gets us in lots of trouble, Time is needed to evaluate these medications, even when time is not what we have. Remember a certain vaccine recently?