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Biogen Alzheimer's drug Aduhelm (aducanumab) wins FDA approval (updated)

Jun. 07, 2021 11:02 AM ETBiogen Inc. (BIIB), ESALF, SAVA, AVXL, LLY, ESALY, RHHBYBy: Jonathan Block, SA News Editor148 Comments
  • The FDA has approved Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALF) Aduhelm (aducanumab), the first new Alzheimer's disease drug since 2003 and the first that aims to slow disease progression.
  • Biogen shares were halted at 10:44 a.m. ET and remain so as

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Comments (148)

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It is probably time for the FDA to establish a new category of approval that has been proposed some time ago. It is basically a full disclosure unproved drug that defers the decision completely to the patient. I realize that in an era where the maxim of "government knows best" despite the repeated failures of that maxim, leaving the choice to the citizenry is a radical idea but this is one whose time has come.
@linkdonald And the citizenry are so well qualified to determine what is safe and effective, never victims of commercial interests, quacks and political opportunists. What could go wrong?
CMLF is working on cure for Alzheimers, in a different method.
Cathy Wood knows about it.
WTJ profile picture
08 Jun. 2021
$56,000/yr is effin' OBSCENE.
Shame on Biogen.
This early Boomer hopes they choke on the money
While this is good news the cost could me prohibitive for the majority of people unless Medicare approves the treatment, a big if this early in the game. All the associated stocks were way up overnight and now all of them are in the red, Wall Street is a fickle bunch, go figure.
bobcowman profile picture
@sarge101abn agree, they can't sell it for that but they can sell it for something, question is how much.
FROGBERT profile picture
This article has a 2" clip explaining the limits monotherapies and the future context of AD drug developement
racerkeith profile picture
What a load of BS! $56k/year and it does nothing to improve/reduce the degeneration of the patient. (First hand knowledge with my 83 y.o. dad)
Ventureshadow profile picture
@racerkeith FDA approval for marketing does not by itself bring approval for use by Medicare, Medicaid or other insurers. Their approval--if it comes--takes several months to a year. They can decide that it isn't worth the cost. Until Medicare approves, FDA clearance is moot.

if it prevents it or substantially delays it, that’s the holy grail
racerkeith profile picture
@kata Unfortunately, for the majority of people prescribed this pharmaceutical it does neither. Still holding out hope for the grail though.
Soylent Green is cheaper and better for the environment.
GreenGrowthGeek profile picture
Not a good drug. This approval bodes well for the other companies that have much better compounds pre-approval. Long SAVA, ANVS, AVXL and CYTH.
Ventureshadow profile picture
Now that adu... is cleared for marketing and BIIB stock shot up, BIIB should be able to buy out Anavex and get a drug that actually works for dementia.
@Ventureshadow I don’t think AVXL will sell for less than 20B. They have their eyes set on becoming the next big pharma. Straight out of the CEO’s mouth
@Ventureshadow A couple new drugs approved in the past few days. Five years from now, which will look more like a blockbuster, NVO’s semaglutide or BIIB’s aducanumab?
@uni102 Good point....likely NVO....not sure why more interest. NVO selling proven results, BIIB selling hope. And hope ain't cheap.
freedomrd1776 profile picture
#SAVA - I invested in it because I believe they have the key to help. Hold Long.
71rbk profile picture
My understanding of biogen’s product is that it has minimal efficacy at best, has to be given IV, and will not be cheap. I don’t know it’s safety profile.
I think it will have no long term significant benefit, but I hope otherwise.
I do believe fda caved in to public pressure and lack of an immediate alternative therapy.

I do think the fda’s decision bodes well for SAVA.
It’s given orally, has no safety issues, and as I recall, also shows limited but somewhat better efficacy than biogen’s drug.
@71rbk safety profile not great. Some patients experienced brain swelling.
@71rbk avxl next in line to strut their stuff... their pivotal phase 2b/3 is 98% enrolled, and its initially dosed patients have completed the trial and opted into an optional trial extension.
total bs. fda is a proven scam now
Hi I’m Paul profile picture
All institutions are corrupted eventually despite whatever intentions they had in their founding, that's to your point. However it was fairly obvious they were going to approve the drug because in their minds it would encourage further research by the industry (I have stated this multiple times over the past two years). I have liquidated my entire position with my calls going up several fold and my commons at around 71% profit.
trading resumes 1:30 : )
rtee profile picture
07 Jun. 2021
This has been a long 2-yr+ roller coaster journey. Congrats to all long who have stuck with this name. Congrats to all those who've been hanging on the hope of Alzheimers breakthroughs!
I’ve never been judgy on people making money in the stock market. Don’t hold it against people that invest in tobacco. Don’t care if you made a million on Bitcoin.
But selling false hope to people suffering from a terrible disease, taking money from their families and the American tax payer.
This is a shame. Don’t care how much it goes up. Glad I’m not a part of this.
@dynx WTH are you talking about? How is the FDA approving a new drug "selling false hope"?
@Ratteau have you read the studies? The ones stopped due to futility? There is no evidence this drug works.
@Ratteau because that’s what it is.... offering hope even though this treatment doesn’t work for most people, and has dangerous potential side effects.
Francis_Mcgillicuddy profile picture
What's stupefying is that this was approved, yet ACAD was rejected recently, after being repeatedly proven effective for relieving some dementia symptoms (behavioral) beyond Parkinsons. If this approval helps patients, that's fantastic. ACAD also helps patients. And caregivers. Maybe this decision bodes well for ACAD's appeal.
GreenAndGreen profile picture
If anyone is looking for an adjacent play, check out Amyris.

Biogen and Amyris delivered a joint study in 2018 designed to test if mAb production could be shifted to genetically engineered microorganisms instead of the traditional CHO framework. The study was a success and we should expect a future-state in which synthetic biology is utilized to produce mAbs for companies like Biogen. See below:

"Global demand for monoclonal antibody-based therapeutics (Mab’s) far exceeds current production capacity, and is expected to continue to grow based on current development pipelines. Despite their proven efficacy in a large number of indications, equitable use of these drugs is limited by the high cost of CHO-cell based production and purification. Micro-organisms such as yeasts and filamentous fungi present an attractive alternative for antibody production, but will require extensive genetic modification to achieve both high titers and mammalian-like glycosylation patterns in a secreted product that is easily purified. Towards this end, we developed state-of-the-art genetic engineering tools for eight micro-organisms to enable the highly efficient, targeted multiplexed integrations necessary for antibody production in these hosts. We demonstrated successful antibody production in several of these micro-organisms, paving the way to low-cost microbial fermentation to replace CHO fermentation."

Source - dc.engconfintl.org/...
CRISPR cures Alzheimer's, all the drug companies make zero. Let's hope it happens.
Hope it helps for the alz caregivers
Dont know how it is for the Alz sufferers though and neither will they
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