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

• 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 of 11:45 a.m. ET. Eisai (OTCPK:ESALY) shares are up 45.3% to $107.90.
• The FDA was supposed to render a decision in March, but in January, it extended the PDUFA date to today to provide additional review.
• Aducanumab's road to approval has been a contentious one as one of two pivotal trials failed and an FDA advisory committee in November vote 8-1 that data from the other trial was not enough to demonstrate efficacy.
• However, patient advocacy groups have patiently stood behind the monoclonal antibody treatment.
• In a blog post explaining the approval, FDA Center for Drug Evaluation and Research Director Patricia Cavazzoni recognized the attention and conflict surrounding Aduhelm.
• "We ultimately decided to use the Accelerated Approval pathway — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit," she wrote.
• Aduhelm's prescribing information.
• Aducanumab is so important to Biogen's future, prior to the announcement of the drug's approval, JP Morgan analyst Cory Kasimov called the FDA's decision "the mother of all binary events."
• Other companies in the Alzheimer's space are moving on the approval: Eli Lilly (NYSE:LLY) +8.9%; Roche (OTCQX:RHHBY) +3%; Anavex Life Sciences (NASDAQ:AVXL) +16.2%; Cassava Sciences (NASDAQ:SAVA) +13.6%.
• The global Alzheimer's disease treatment market is expected to grow at a compound annual growth rate of 12.8% between 2020 and 2027, reaching more than $5.6B by 2027, according to a report from Acumen Research and Consulting.

Comments

[linkdonald]

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.

[Doneonbadstreet]

@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?

[Doneonbadstreet]

@linkdonald Quackery, unproven cures, treatments etc.

en.wikipedia.org/...

www.historyonthenet.com/...

brewminate.com/...

www.ncbi.nlm.nih.gov/...

blog.socialstudies.com/...

www.aao.org/...

www.wikidoc.org/...

www.atlasobscura.com/...

www.newscientist.com/...

[tiffiny vanvorken]

CMLF is working on cure for Alzheimers, in a different method.
Cathy Wood knows about it.

[WTJ]

$56,000/yr is effin' OBSCENE.
Shame on Biogen.
This early Boomer hopes they choke on the money

[sarge101abn]

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]

@sarge101abn agree, they can't sell it for that but they can sell it for something, question is how much.

[FROGBERT]

This article has a 2" clip explaining the limits monotherapies and the future context of AD drug developement
amosinstitute.com/...

[racerkeith]

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]

@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.

[kata]

@racerkeith

if it prevents it or substantially delays it, that’s the holy grail

[racerkeith]

@kata Unfortunately, for the majority of people prescribed this pharmaceutical it does neither. Still holding out hope for the grail though.

[TexJones]

Soylent Green is cheaper and better for the environment.

[GreenGrowthGeek]

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]

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.

[brad_scat]

@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

[uni102]

@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?

[LiveFreeAZ]

@uni102 Good point....likely NVO....not sure why more interest. NVO selling proven results, BIIB selling hope. And hope ain't cheap.

[freedomrd1776]

#SAVA - I invested in it because I believe they have the key to help. Hold Long.

[71rbk]

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.

[brad_scat]

@71rbk safety profile not great. Some patients experienced brain swelling.

[brad_scat]

@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.

[jeffk100]

total bs. fda is a proven scam now

[Hi I’m Paul]

@jeffk100
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.

[doctahJonez]

trading resumes 1:30 : )

[rtee]

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!

[dynx]

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.

[Ratteau]

@dynx WTH are you talking about? How is the FDA approving a new drug "selling false hope"?

[dynx]

@Ratteau have you read the studies? The ones stopped due to futility? There is no evidence this drug works.

[brad_scat]

@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]

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]

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/...

[8675309jenny]

CRISPR cures Alzheimer's, all the drug companies make zero. Let's hope it happens.

[d0d0ramefasolated0]

Hope it helps for the alz caregivers

[d0d0ramefasolated0]

Dont know how it is for the Alz sufferers though and neither will they