https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval Skip to main content ScienceMag.org Search X [ ] Advanced Search * Contents * News * Careers * Journals Share In the pipeline Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek's own, and he does not in any way speak for his employer. Derek Lowe By Derek Lowe * * * Alzheimer's Disease The Aducanumab Approval By Derek Lowe 8 June, 2021 As the world knows, the FDA approved Biogen's anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because - like the advisory committee that reviewed the application, and like the FDA's own statisticians - I don't believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy. They will be absolutely overjoyed to do that, of course, because the whole time that's going, they will be selling the first drug that (in theory) targets the etiology of Alzheimer's. The backed-up demand is going to be gigantic, and Biogen is going to make enormous amounts of money. They have nine years, as it turns out, to get this trial done, and I feel safe in predicting that it's going to take alllll niiiiine loooong sloooow years to get this done. Why shouldn't it? The company certainly showed no interest whatsoever, not even a twitch, in running a confirmatory trial before this, so why should they hop to running one while the drug is selling? I continue to think that odds are quite good, and certainly unacceptably so for Biogen, that the drug will turn out in the end to have no real effect on Alzheimer's patients at all. I've been dreading a decision like this for a long time. So the FDA has, for expediency's sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed. I really, really don't like the precedent that this sets: what doesn't get approved, now? I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit? I know that this is just the libertarian turn that many people have wished for, but I'm still not sanguine about it. I'm going to quote myself, because my opinion hasn't changed a bit: What would be so bad about moving to an "efficacy not required" regulatory regime? I think that it's a flight from scientific evidence, which is the only thing we've got. Otherwise, everything starts to look like the "dietary supplement" industry, and what a mess that is. Here, you drop the efficacy requirement and I'll develop grape juice for Dread Disease X. Not just plain grape juice - grape juice concentrate capsules. Mechanism? It's the bioflavanoids. Probably. I think that they're antioxidants, among other things. Lots of things. I can show safety in the clinic, too, so you have to approve my grape juice gel caps: I have a mechanism by which they might work (you can't prove I'm wrong, can you?), I can show they're safe, and you've eliminated the requirement that I prove that they actually do anything useful. Off to market! The patients who unfortunately suffer from Dread Disease X will, I'm sure, pay a lot for something that might help them. Don't they have a right to try my antioxidants? There's nothing else like them on the market, you know. Go ahead and laugh - I mean, yeah, I'm pretty amusing, but I don't keep grinning as long as I might when this topic comes up. The aducanumab approval, to me, is just a tiny step off of the radio-ad "Not intended to treat, cure, or modify any disease" memory supplements. It's true that those ads always have to work in the line about how "These statements have not been evaluated by the FDA", and at least Biogen doesn't have to say that. Their statements have indeed been evaluated by the FDA, and the FDA has decided to punt on all the important ones and just let Alzheimer's patients, their families, their insurance companies, and the taxpayers (through Medicare and the VA) pay for it all while we figure it out somewhere around the year 2030 or so. Here's Matthew Herper at Stat, talking about that exact FDA rule-change problem, and here's Damian Garde and Adam Feuerstein trying (perhaps in vain) to estimate just how much money Biogen could be reaping from all this. That's partly because, as Andrew Joseph notes, the agency applied no restriction at all to what patients can get the drug. Steve Usdin is gloomy about this at BioCentury, and wonders if this is going to open the door to many more such approvals in neuroscience and beyond. Zach Brennan's not happy at Endpoints, either, and neither is their Bioregnum column. In general, the more you know about drug development and drug approvals, the more likely it seems that this decision came as an unwelcome surprise. That probably goes for plenty of people inside the FDA, come to think of it. This was disgraceful decision, and we're all going to be dealing with the consequences of it for years to come. 49 comments on "The Aducanumab Approval" 1. [c4a] Daren Austin says: 8 June, 2021 at 8:59 am "I really, really don't like the precedent that this sets: what doesn't get approved, now?" Technically, I think Sarepta set the precedent, but I share the sentiment. Proof-of-Pharmacology based conditional approvals for safe-but-hard-to-prove potential medicines? Reply 2. [9eb] Connie L Luthy says: 8 June, 2021 at 9:01 am While I'm inclined to agree with you, Derek, the only counter I can think of is that the FDA knows about ALL sponsor's data/ results. I'm just guessing (hoping) that Biogen's beta-amyloid clearing data is better that that of other drug candidates studied in man. Yes, I realize the the connection between beta-amyloid deposition and loss of memory and cognitive ability remains unclear. Think of it as the Infusion Center full-employment act. Reply 1. [f4c] Patrick says: 8 June, 2021 at 4:44 pm Ok, but did their advisory committee *not* know about it? I'll just go ahead and say it: This drug doesn't work. It doesn't help with Alzheimer's. We are *almost certain* of this. The trial was literally *halted for futility*. Jesus fuck. Reply 3. [cda] LL says: 8 June, 2021 at 9:04 am The decision should have been deferred until a new trial either confirms or refutes an efficacy signal - not before. We will see if the FDA will be able to take it off the market again in case the post-approval committed trial turns out negative. There should be a detailed review on sponsors, lobbying groups etc. who were involved in pressuring the FDA. The scientific advisors to the FDA recommended 10:0 (with one abstinence) against approval. And the price tag in the US is supposedly 56 k USD / year. Reply 4. [ad3] OnceAChemist says: 8 June, 2021 at 9:11 am The Addyi approval after two previous FDA rejections was another step on the same slippery slope. My impression was that the final approval was driven primarily by a massive lobbying effort and social media campaign. Reply 5. [c22] Petros says: 8 June, 2021 at 9:14 am It will be interesting to see what the EMA's CHMP recommend when they review it later this year. past experience suggest that approval will not be recommended. Reply 1. [a17] Lambchops says: 8 June, 2021 at 10:16 am I wouldn't be surprised if they didn't recommend it - from what I've seen the EMA is more cagey with CNS approvals than the FDA. At the very least expect a much narrower patient population (contrast the labels for cannabidiol for epilepsy - where the EMA label requires taking cannabidiol in conjunction with clobazam). As I've mentioned on these blogs before, I think it's crushingly inevitable that there will be pressure on the MHRA in the UK for quick approval so that Boris can trumpet the glories of Brexit and fast approvals compared to the EU (cost-effectiveness evaluation is of course another issue - but I'd still rather see the regulators hold up evidence standards). Reply 6. [bc3] myma says: 8 June, 2021 at 9:28 am It will also be interesting if-when-how-where Medicare-Medicaid covers this. Its an infusion, so its not just the list price of the stuff itself (~$5k each once a month dosing), its also the infusion center outpatient cost too. I used the word "stuff" because the word "medicine" seemed inappropriate. Reply 1. [5ec] JasonP says: 8 June, 2021 at 2:56 pm This is a key point! Whether The Centers for Medicare-Medicaid approve Aduhelm for payment or not. They use a criteria of how paying for the treatment effects patient outcomes and I am sure the economics of such. After all widely used in research, the PET AB & Tau tracers are NOT approved. This could be key in the eventual profitability. Reply 1. [3ae] Another Idiot says: 8 June, 2021 at 5:46 pm Agreed. If Medicare doesn't approve it then neither will insurance companies. Reply 7. [a75] Tom says: 8 June, 2021 at 9:33 am Derek, your grape juice analogy is not quite correct. As far as I know, grape juice doesn't lead to Amyloid Imaging Related Abnormalities in 41% of treated patients, or brain oedema in 40% of APOE e4 carriers. Reply 8. [3e4] Dr. Manhattan says: 8 June, 2021 at 9:34 am Not mentioned is the added fact that in addition to no statistically decent proof of efficacy, on the Safety side there were a significant number of cases of swelling in the brain. These caused patient confusion and sometimes falls. So, questionable efficacy data but a safety signal. There was a very good reason for the expert panel to recommend not approving the drug. And added to that is the cost for the molecule that would be primarily in older adults, and the burden placed on insurers such as Medicare. Are thousands of dollars per patient per year worth the expenditure if the trial results are suspect? How much additional cost from patients treated for the side effects? A few years back, my company put a highly effective compound into man, but that turned out to cause elevated liver enzymes. Stopped the trial immediately, as should be the case. We come a long way from that time, and not in a good direction. Reply 9. [d9a] Kiss the Chemist says: 8 June, 2021 at 9:34 am If this turns out to be a turkey we will only know NINE YEARS FROM NOW?! How the hell do we get the genie back in the bottle, potentially with other "me-too" antibodies on the market, and patients who want to keep being treated (based largely on false hope)? Reply 1. [a17] Lambchops says: 8 June, 2021 at 10:20 am Not to mention the opportunity costs. The research money inevitably splurged on "me-too" antibodies could potentially be better spent looking at other avenues of research. Reply 1. [5ec] JasonP says: 8 June, 2021 at 3:09 pm Oh come on! Research in drugs for AIDS didn't stop just because the FDA fast tracked AZT. Plus it appears that with titration, ARIA can be managed. Many of the ARIA appear to self resolve with time as well The eventual "cure" for ALZ will end up being a cocktail or series of drugs, not one Silver Bullet. Clearing amyloid could be one part of the solution. Other avenues likely to include inflamation, Tau removal and microglial dysfunction. Reply 1. [f4c] Patrick says: 8 June, 2021 at 4:54 pm Oh come the f* on. We have approved a medication that does not help Alzheimer's patients, which *we do not know how to do*. We *know how* to make amyloid clearing antibodies, and now companies are allowed to sell them. AZT ramped up research in antivirals because it showed we knew how to make medicines to help control AIDS (specifically antiretroviral small molecules). It likely sucked money out of competing approaches, which is fine, since the general approach of antiretroviral small molecules is a good way to fight HIV/AIDS and most of those other approaches were probably less good. Companies followed the money, doing the thing they knew how to do and were allowed to sell. Because the regulator insured this was beneficial to patients, we all benefited. THIS will drive up research in to medicines that help clear amyloid. Because we know how to do that. Patients be damned. Your statement that this is fine because it might help in some theoretical future world is pretty deeply useless in the context of current approval. It has no benefit NOW (it will in fact hurt people, it's got some pretty bad side effects that should only be tolerated in the context of significant benefit), and it will not cease to exist if not approved. Reply 10. [fb8] Radioactive Man says: 8 June, 2021 at 9:43 am All the other companies that successfully developed anti-amyloid drugs then discontinued them for lack of efficacy must be kicking themselves to realise they were approvable all along. Reply 11. [d2f] Sok Puppette says: 8 June, 2021 at 9:54 am I'm one of those types who take the libertarian view, and I want to say that this is *not* what I'm looking for. This isn't just people being allowed to evaluate evidence for themselves, or make their own decisions. FDA approval is an active statement from the government that the drug is safe and effective. The government has no basis to issue such a statement. What *should* be going on is that FDA approval should be advisory only. But it should still never be given for anything that doesn't actually meet the stated criteria. ... and, by the way, I don't buy "proven safe" as a criterion and I don't think anybody who's thought about it has ever suggested that. Lots of things that clearly *are* beneficial are still not "safe". In fact, the word "safe" is a magnet for sloppy thinking. It's always a matter of trading off the probability and magnitude of the desired effect against the probability and magnitude of undesired ones. Reply 1. [3e4] Dr. Mahnattan says: 8 June, 2021 at 10:57 am I agree that it's true that many drugs are not *proven* safe, but can have an acceptable safety risk profile. The drug dosages can be managed to provide efficacy with a minimal safety risk. Effects such as CV arrythmias, liver & renal damage and other serious consequences are at one end of the spectrum. In the case of this drug, there were reports of brain swelling, in one report, 30% of the patients. Depending on how that plays out over time in larger populations, it may be consequential in some patients. Reply 2. [f4c] Patrick says: 8 June, 2021 at 4:59 pm Drug trials are hugely expensive, and unless you dispute that large, randomized, controlled trials are the only way to really determine safety and efficacy, then how do you propose they be paid for if approval if only advisory? The only reason they are run now is companies do not have a choice. You simply have to look back pre-FDA (or now, at the dietary supplement market, where almost nothing has much benefit, but it sells like crazy!) to see what they do when given a choice. And if you suggest that people will demand these trials even when they're not required by law, I think you just need to look at the past year of pandemic to see how wrong that is. There are many, many people even in the medical establishment happy to "go with their gut" or run trials far too small to show what they're claiming. Reply 12. [56e] Dan Elton says: 8 June, 2021 at 10:01 am A couple quick comments (much more could be said): -- The FDA historically has been overly cautious, resulting in more Type I errors (failing to approve a good drug) than Type II errors. (see https://alo.mit.edu/wp-content/uploads/2015/08/ FDA18b.pdf, published in SSRN). Type I errors are insidious because they fly under the radar. With a Type II error, the drug can be pulled off the market after follow up RCTs or Phase IV show it actually doesn't work. (as a side note the Type I / Type II balance seems to depends on the type of drug - for instance in cancer drugs there seems to be an over-reliance on biomarker studies leading to what Vinnay Prasad calls "medical reversal" and too many Type II errors). -- there isn't any other treatment available, and AZ is a devastating condition. So it is arguably ethically cruel in this case to withhold a treatment that has some evidence to support it (even if it is weak evidence). -- the FDA is requiring a post-market efficacy trial. This is great. The problem is the FDA (from what I've heard) sucks at enforcing these things. They need to enforce that it be done in a timely fashion and if the trial comes back showing no benefit they should pull the drug off the market. After all, selling something claiming it "works for indication X" when in fact it doesn't work for X is fraud. -- A rational and ethical approach to approvals should factor in unmet need and lower efficacy standards to get to market for drugs that have a chance at fulfilling an unmet need. The FDA should really have multiple tiers of approval or use adaptive licensing. At the top of these tiers would be the "gold standard" approval for safety+efficacy which means there is strong evidence for effectiveness. But there should be other levels too to get promising drugs to market faster and save lives and reduce costs. And there should be better post-market surveillance and recall of drugs where the evidence accumulates that they don't work. Reply 1. [4fe] MrXYZ says: 8 June, 2021 at 11:00 am These are interesting comments. The 'tiers of approval' idea is interesting but I am not sure how that would affect the industry since marketing approval is essentially a binary event (do you get to sell the product or not)? Obviously, enforcing post-marketing is key and unfortunately the government is much better at making rules than enforcing them (which requires giving agencies appropriate funding and authority for enforcement). Also, I am curious about your first statement. How do we know that the FDA has made more Type 1 errors than Type II errors? Is there a good review of NDAs/BLAs that have not been approved (as opposed to drugs that failed but never submitted an application). Could be an interesting read. Reply 2. [156] metaphysician says: 8 June, 2021 at 12:32 pm Put bluntly, neither doctors nor the fda should be in the business of providing "hope". If you want hope, go to a church. Doctors, and the fda, should only be providing hard headed pragmatic fact. If there isn't a treatment for your terrible illness, they should tell you that, not lie to you out of some misguided aversion to "cruelty". Reply 3. [e03] John says: 8 June, 2021 at 3:12 pm Do you know much time Biogen has to complete the trial ? 11 years. At 56K * 3 mil patients= $160 BILLION of sugar pill PLUS cerebral edema and death in quite a few! Also, when the confirmatory trial ends, the patent expires ! why the hell do they have to even do the trial? Just pull the drug off the market by 2031 Reply 4. [eca] Brian says: 8 June, 2021 at 3:54 pm Why exactly is it up to Biogen to run the confirmatory trial? That's just how it works right now, but isn't it an obvious flaw with an obvious solution? Get another government agency to do trials like that. NIH maybe. Make marketing approval for aducanab conditional on setting aside $X billion for that agency to use on the confirmation trial. That way we can get it done in a reasonable amount of time at least. For that matter, it seems like there's a lot of example of non-pharma or off-patent treatments that could use a good clinical trial, where the normal industry profit motive doesn't work. We should probably separate these functions. Reply 13. [e87] Erik says: 8 June, 2021 at 10:10 am Welcome back to 19th century medicine! A hundred years ago the American Medical Association got its act together and got rid of reams of quackery, condensing to only DOs and MDs. They still have the ultimate power in this system (in many ways - for example, state prosecutors rarely go after the rare doctors who harm patients before getting the okay from the state board of medical practice, or they allow the board to deal with it) but they've abrogated that power for so long by sticking their heads in the sand they're basically shills for the exact same quackery they banded together to eliminate back then. Does it matter if the licensed physician treats with less-than-placebo (e.g. no effect yet causes harm such as a ~40% rate of brain swelling) or we simply allow dietary supplement makers to start making the same claims? Heck, at least those USP-manufactured supplements cause less harm... The physicians need to stop ignoring the damage that has happened _under their watch_. Reply 1. [e87] Erik says: 8 June, 2021 at 10:11 am Whoops, that's 40% of APOE-e4 carriers, not all patients, my mistake. However, that group is going to be over-represented in the treatment groups. Reply 14. [398] Running Comment says: 8 June, 2021 at 10:33 am Most BACE inhibitors and Abeta-clearing mAbs have shown effects on Abeta, sometimes dramatically so; in the absence of clinical benefit, however, the sponsors of these products correctly decided to pull the plug. Are we now going to see Merck, Lilly and Roche and Eisai et al. submitting their (equally) incomplete dossiers ? Why not ? The door is open... Re. the confirmatory trials, I believe I am quoting Derek from some time ago: "Real treatments work again when you test them again, and they continue to work when you test them under more controlled and more statistically powered conditions." Reply 15. [6b9] Metacelsus says: 8 June, 2021 at 10:50 am And to think that the FDA still hasn't given full approval to COVID-19 vaccines based on "an abundance of caution". Where was that caution now? Reply 16. [fa6] anonnymous says: 8 June, 2021 at 10:50 am Bonanza for Biogen! Bag of crap for tax paying citizen of the US! Reply 17. [382] David says: 8 June, 2021 at 11:14 am A few predictions: 1) Biogen will take a long time to "negotiate" with FDA on the design of the confirmatory trial, effectively delaying the start. 2) The trial will have very restrictive Inclusion/Exclusion criteria, ensuring that there will be few patients available to enroll, 3) Biogen will focus on sites that use local IRBs, increasing study startup time, 4) the study sites will be exclusively academic medical centers, on the pretext that these generate the best quality data, but in reality for the reason that academic medical centers are notorious for slow recruitment, 5) Biogen's marketing team will place significant resources to increase prescription use in the regions selected for the study, thereby competing for patients with study recruitment. 6) At the end of 9 years, the study will be just a little over half-recruited and Biogen will request a deferral on the timeline. 7) The availability of open-label treatment will lead to a high discontinuation rate in the trial, so the final results will be uninterpretable. Reply 1. [7a9] tnr says: 8 June, 2021 at 3:35 pm Good call. Reply 18. [fb8] Radioactive Man says: 8 June, 2021 at 11:28 am $56,000/patient/year x 5.5million patients in the US = $308 BILLION/year. Even if only a small fraction of patients actually get it, this will easily be the most lucrative drug of all time. Reply 19. [c42] Flask Monkey says: 8 June, 2021 at 11:35 am The FDA approved it but will the insurers pay for it? Reply 1. [a9c] Ken says: 8 June, 2021 at 11:50 am That's why I'm planning to sell it as a homeopathic preparation over-the-counter, ten bucks for a month's supply. Any challenge by the FDA or Biogen will be countered by saying that the pills contain not one molecule of Aducanumab, so are not covered by FDA regs or Biogen patents. Any challenge on the grounds of efficacy will be met with a sneering laugh, and a press release on the subject of "giving hope to millions who can't afford big pharma's prices". Reply 20. [62c] Hop Along says: 8 June, 2021 at 11:37 am I can't believe that the FDA handed Biogen the keys to a multi-billion dollar franchise based on ambiguous data with no clear benefit. I hoped that the best outcome was the requirement for another confirmatory trial, correctly designed and powered but I just don't understand this decision especially if you consider the broader usage label. If this is an emotional decision it really sets a poor precedent for the FDA and I can envision they will be sued by every Pharma Bro looking to get approval for some half baked compound. If I were in the legal profession I would already start drafting my new ad for daytime TV "Have you or a loved one been injured by Aducanumab?" Reply 21. [7b5] Adam says: 8 June, 2021 at 11:45 am This actually makes Prevagen look like a pretty good option. Same placebo effect, a fraction of the cost, better safety profile. Reply 1. [3e4] Dr. Manhattan says: 8 June, 2021 at 12:34 pm I'm not sure about the Prevagen safety profile. I noticed in the television ads that they all seem to be moving in slow motion. Perhaps they are "thinking fast and slow" and that's why they think it works? More time to ponder things if you are living in slow motion? Still puzzling how a Jellyfish protein, beside have a non-obvious pharmacological effect on cognition, gets through the stomach, across the intestinal tract, into the blood and through the blood brain barrier. Reply 1. [7b5] Adam says: 8 June, 2021 at 12:46 pm That's assuming some sort of QA on Prevagen; it seems fairly likely the product on the shelf doesn't contain any Jellyfish Nobel Prize protein. Maybe its just sugar, which distributes quite nicely across the BBB and has a number of positive effects. Reply 2. [604] debinski says: 8 June, 2021 at 1:07 pm I have always wondered what poor suckers fall for the jellyfish protein as some wonderful brain saving ingredient. But it does look pretty neat when they show the jellyfish swimming around all lit up - I guess the point is to imply it "lights up" the brain? There's so much money wasted on supplements - but nothing that will compare with Aducanumab it sounds like. Reply 22. [a0c] Sunyilo says: 8 June, 2021 at 11:58 am Just to add some background info how aducanumab was discovered: the antibody was derived from a screen by Neuroimmune who cloned B-cell products from Swiss individuals who grew to an old age without any symptoms of neurodegenerative diseases. What this approval tells us about our society in 21st century America? Go and monetize some insights into the conditions affecting many-many millions in our country and everywhere else instead of securing healthy living conditions to our population. Just as with the diabetes epidemic in the US. Reply 1. [f4c] Patrick says: 8 June, 2021 at 5:04 pm The Swiss individuals had genetic differences... The population level rate of Alzheimer's is around 1.73% in Switzerland and around, a horribly worse and shocking ...... 1.8% in the US. Since I couldn't find a single shared source for both of those numbers, I think it's safe to say they're within the margin of error. Reply 23. [156] metaphysician says: 8 June, 2021 at 12:38 pm I am going to say something horrible: the best outcome we can hope for now is that aducanumab swiftly and unambiguously kills a large number of its recipients. The only way this won't set a terrible precedent is if the people responsible, at both the fda and Biogen, are splashed with career-ending levels of blood. Aducanumab needs to be the next thalidomide. Reply 24. [37a] Eric Kishel says: 8 June, 2021 at 12:51 pm Could insurance companies just not cover this treatment, citing lack of efficacy? If it doesn't improve the standard of living, or in other words does not offer any real value to the patient, then it certainly does not to insurance companies. They won't be paying for a reduction in risk of larger expenses down the road, they'll be paying something for nothing. If not them, what's the next line of defense? Prescribing physicians? Pharmacists? Appreciate any insight that anyone can provide. Reply 25. [357] a says: 8 June, 2021 at 1:35 pm Given the VAST moral hazards instantiated with this ridiculous approval, desperate times call for desperate measures. Are there any legal ways to get the FDA to rescind approval defacto or dejure? Lawsuit? Passing a Law? A Rule/Regulation? If we went down this route, I think theres a likelihood we're in "there once was a lady who swallowed a fly" territory by stopping a FDA approval, but it's too important to just shrug our shoulders and go, "eh". Reply 26. [7a9] tnr says: 8 June, 2021 at 2:26 pm The lack of FDA consistency between Aducanumab approval and the requirement that Amylyx run another Phase III study of its ALS compound is really troubling. Both were probably reviewed by the same Division at the FDA, so why require that Amylyx run another Phase III study when its small study hit on the primary endpoint AND overall survival??? Reply 27. [c07] DC Medchem says: 8 June, 2021 at 2:40 pm President Biden has yet to nominate a permanent FDA Commissioner, unless I've missed a recent announcement. It will be interesting to see if this decision is discussed when confirmation hearings eventually take place. Reply 28. [7ea] drsnowboard says: 8 June, 2021 at 4:03 pm when wishful thinking allows an FDA drug approval, we're screwed. Will make Valium, opioids, Skhreli look like mere blips. Reply 29. [824] MikeC says: 8 June, 2021 at 4:33 pm The most charitable excuse I can think of is that the top of the FDA was not ready to face the barrage from patient advocacy groups (weaponized by Biogen and Eli Lilly) that would have ensued after non-approval. Maybe they are hoping that another drug will be approved soon and then they can find an excuse to kill off aducanumab? The best case scenario now: an investigation or expose torpedoes the approval before any prescriptions are infused. Reply Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * [ ] [ ] [ ] [ ] [ ] [ ] [ ] Comment [ ] Name * [ ] Email * [ ] Website [ ] [ ] Save my name, email, and website in this browser for the next time I comment. Time limit is exhausted. Please reload CAPTCHA. nine - [ ] = three [Post Comment] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] This site uses Akismet to reduce spam. Learn how your comment data is processed. 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