An Alzheimer's Breakthrough, At Last - WSJ
By: The Editorial Board (WSJ)
S E E D E D C O N T E N T
The Food and Drug Administration gave hope to millions of Americans suffering from Alzheimer's disease on Monday by approving Biogen 's aducanumab, the first treatment shown to slow cognitive decline. Credit to Acting Commissioner Janet Woodcock for resisting pressure from the public-health left who campaigned against the drug.
Aducanumab's twisted path to approval illustrates the challenges of drug development. Hundreds of experimental Alzheimer's treatments have failed in clinical trials over decades. While some approved drugs can temporarily mitigate behavioral and cognitive symptoms, none before aducanumab had shown an impact on disease progression.
One reason a breakthrough has proven elusive is that researchers haven't figured out exactly what causes Alzheimer's. Its hallmark is an accretion of amyloid plaque and tau tangles in the brain, which usually begins long before people show symptoms. Some scientists believe that removing amyloid could slow disease progression.
Enter aducanumab, which is a monoclonal antibody cloned from older people who showed unusually slow cognitive decline. It works by clearing amyloid. A high dose of the drug in a late-stage trial removed 71% of the amyloid buildup after 18 months.
Yet more than two dozen experimental drugs targeting amyloid have failed to show benefits. Two years ago, aducanumab looked to be another failure after a midpoint "futility analysis" of two Phase 3 clinical trials with some 3,200 participants apparently showed no benefit.
Biogen halted the trials, only to discover months later in a post-hoc analysis that the termination was premature. In one trial, patients receiving a high dose of the drug demonstrated significant benefits. They showed 28% less memory decline than the placebo group, and benefits were greater for everyday tasks like making meals.
Patients receiving the high dose in the other trial didn’t show a significant benefit. Biogen believed this was because they got the drug for less time. After working with Biogen to analyze the data, the FDA described the results as “exceptionally persuasive.” An outside advisory panel disagreed, but none of its members actively treated Alzheimer’s patients.
The panel lambasted Biogen for massaging the data. Groups on the left attacked the FDA for collaborating with Biogen. They claimed the FDA would be lowering its standards and compromising its objectivity if it approved the drug. But collaboration between drug makers and FDA is why Americans have three effective Covid-19 vaccines.
As for complaints about insufficient evidence, Congress amended federal law in 1997 to let the FDA approve novel drugs based on a single study in order to accelerate breakthroughs for hard-to-treat diseases. The FDA has appropriately exercised its discretion, and Biogen plans to conduct additional studies following drug approval.
Critics also argued that aducanumab’s benefits are modest, but tell that to patients and their caregivers. Incremental progress often drives drug development. Aducanumab won’t help all patients, but it could delay disease progression as research continues on potentially more effective treatments. More than 70 are in the clinical pipeline.
The real progressive objection seems to be cost more than effectiveness. New blood tests can identify the disease years before signs of cognitive decline, so the potential patient pool may soon expand. But Alzheimer’s costs the U.S. an estimated $277 billion a year, and early treatment will be crucial to slowing progression.
The FDA’s approval offers much-needed reassurance to U.S. drug makers that it won’t bow to political pressure and let biotech breakthroughs go to waste.
Tags
Who is online
87 visitors
Good old Biogen, right over here in Cambridge MA. To think this breakthrough may have been missed!
There is hope for Joe Biden.
Some of us have friends and family who died after years of decline with Alzheimer's. Not really something I recommend joking about.
That's in poor taste!
It's horrifying to watch someone deal with such decline. And modest benefits are better than no benefits!!! The only thing "wrong" with my great grandmother [on my mom's dad's side] was Alzheimer's... she was 96.
When there's a higher demand and insurance companies get on board... the cost will decline and usually after 2 years of a medication being on market, a generic is developed, which is even less expensive.
Good. The FDA shouldn't be involved in politics.
AMEN!
My father died from dementia at age 99 in 2019, otherwise he was in OK shape for his age. It is horrifying to watch someone decline from dementia, for us it was about 3 years of watching dad mentally slip away, often reverting back to childlike state, tantrums, crying, etc., broke our hearts, especially moms. At the end his body shut down, losing the ability to even swallow. Any breakthrough, even the slightest, is welcome.
He probably had Alzheimers. Dementia is memory failure, Alzheimers is a brain disease. They're not the same.
He was diagnosed with dementia, below are the symptoms, of which he had majority.
Cognitive and sensory changes:
Psychological changes:
Dementia is a general term for a decline in mental ability severe enough to interfere with daily life. Alzheimer’s is the most common cause of dementia. Alzheimer’s is a specific disease. Dementia is not.
My condolences about your father. Dementia or similar decline in one's faculties is terrible. It's something we're seeing more and more today and it's quite a shame.
Not sure what your point is, my dad died and it was horrible to watch, you want to quibble about cause? You do NOT know what my father had, so please stop trying to act like you know.
It is a mighty sad and horrible way to go.
Great news
F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
From the article, there is Phase 4 testing to be done yet. Let's hope that it shows help for this horrible diease.
I have been an investor-- and occasionally an active trader-- in the stock market for many years. About 4 years ago I bought shares of Biogen as it looked like the leader in research for a cure for Alzheimers. (In addition, IIRC unlike many diseases which have many, many companies working on a cure for them, Biogen was the only-- or one of the only, companies focusing on this) Of course the stock was volatile, moving up and down on news-- as well as rumours.
Every so often there seemed to be a hint of a major breakthougt-- akways followed by a disappointment. There seemed to be a pattern-- I trimmed and eventually liquidated my entire position.
Of course as people in the market often say:
Past results are not indicative of future performance.
So yes-- it is possible that this time it will be a significant breakthrough-- I hope it is!
However I do not currently own the stock and have no intention of buy any-- this one is too speculative for me.
This means there is a significant breakthrough, but I wouldn't get my hopes up.
P.S: Unsurprisingly the stock had a really big pop yesterday. But it closed down (albeit slightly) today.
Which means that a lot of the "smart money" was selling. (In and of itself that might not mean much...but.)
This drug is going to be very expensive , thousands of dollars per month (I heard 5000). Is insurance going to cover it for everyone? Is Medicare going to cover it?
Or is it going to be a medical miracle only for the wealthy and those who will have to spend their life savings on it?
Very few people can afford that unless it is almost entirely covered by insurance.
It will be interesting to see how this cost is going to be taken care of...Insurance, government intervention/support (financial) of just the open market, if you have the money you're good if not you're screwed.
Agreed, that is too pricey for a viable market. There are ~6 million Alzheimer's patients in the USA. I would expect the prices to drop to capture that volume.
Well, they need to charge a lot for it so that they can continue to flood the country with millions of expensive commercials all day long that all end in such helpful information as “don’t use this this drug if you are allergic to it” and “may cause death”.
The median annual household income in America isnt much more than that.
I like the way the ads tell you all the ways you can get sick or die from a drug that is presumably saving your life.
There is a YUGE field of "alternative medicine"-- everything from Accupuncture, to Herbals medicine, to meditation, and more. In many casesthese modalities as just as effective as conventional Western Medicine-- if not more so. And most do not have the side effects that concentional Western medicine (which is mainly either strong drugs or surgery) has.
I am not aware of any successful treatment of Alzheimers, however there is evidence that a healthy lifestyoe (particularly diet0 may greatly lessen the chance of not getting the disease.
I believe they have to do that to "cover their asses". (If a person dies or gets seriously ill from a particular drug and the manufacturer did not issue warnings about possible negative effects of the drug I believe it would be much easier to sue them for yuge amounts of money.
Hence the “Don’t take Flacidix if you are allergic to Flacidix”. Ummm ... how do I know if I’m allergic to Flacidix if I don’t try it? Don’t care - you were warned so we aren’t liable!
I really do not like those ads
You went from skirting to a personal attack and you have also mischievously removed my flagging ability. And now you removed the comments.
What skirting, what personal attack?? I did not remove your flagging ability (I do not operate as a moderator). Get a grip man.
Now you are going to pretend you don't know who did it?
Perrie admitted it.
What on Earth are you talking about? Perrie admitted what? Your flagging? You accused me of removing it. And where is the skirting / personal attack you have claimed?
Get a grip.
Vic,
Yes, I did remove your ticket to Tig. It was not a skirt. No Tig had nothing to do with the removal nor did he do anything with your ability to flag. You can still flag and moderate your own group within the CoC guidlines.
I am stating this for transparency.
Thank you.
I would not count my chickens quite yet. Heard about this yesterday and there is still quite some debate on the efficaciousness of the drug and its ability to actually slow the progression of the disease.
I agree