Instead, I worry that this kind of process will be used by sponsors of new drugs that have been fast tracked in other countries, such as #aducanumab (often on the basis of surrogate endpoints) and have limited evidence of effectiveness but high prices.

I also explain how this mechanism, if in place in 2021, could have allowed the entry of #aducanumab into Canada. A drug USFDA approved for Alzheimer's disease but which our regulator + the European Medicines Agency effectively rejected due to its poor effectiveness and significant safety risks.

Aducanumab amyloid-β-clearing strongest in superficial cortex Treatment with the anti-amyloid-β antibody aducanumab clears amyloid from superficial cortical layers more than in deeper tissue.

#MedNews - Treatment with the anti-amyloid-β antibody #aducanumab clears amyloid from superficial cortical layers more than in deeper tissue.

Full story 👉 buff.ly/XLteVb3

#NeuroSky #Alzheimers

Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals This study uses US Food and Drug Administration (FDA) data to characterize pivotal and confirmatory trials supporting agency decision-making in the context of the FDA accelerated approval pathway for ...

such as #aducanumab for #Alzheimerdisease, #tofersen for ALS , #delandistrogene #moxeparvovec for #Duchennemusculardystrophy & #voxelotor for #sicklecelldisease
@jama.com

ja.ma/3GHGhDE

jamanetwork.com/journals/jam...

Like #Prasad, I had also strongly disagreed with way #eteplirsen and #aducanumab were approved. It is not about being all or nothing, but nuance.

Science Cast Increase your recognition in the scientific world with short video-casts

🚨Preprint 🚨 Epitope Sequence and Modification Fingerprints of Anti-Aβ Antibodies. This resource aims to advance AD diagnostics & therapeutics. Looking forward to reviewer feedback!

Audio summary:
sciencecast.org/casts/ca9qhd...

#AlzheimersDisease #aducanumab #donanemab #lecanemab

Meaning of #aducanumab It is the name of an experimental drug that is being developed to eliminate the harmful protein plaques amyloid-beta that is deposited in the brain in mild and initial phases of disease of Alzheimer.Esta being developed by the Biogen laborat.. aducanumab

Significado de #aducanumab É o nome de uma droga experimental que está sendo desenvolvido para eliminar as placas de proteína prejudicial da beta-amiloide, que é depositado no cérebro nos estágios iniciais e suaves da doença de Alzheimer. Está sendo desenvolvido p.. aducanumab

Excess Mortality in Alzheimer’s Patients on Anti-Aβ Monoclonal Antibodies Introduction It is unclear how the reported deaths of Alzheimer’s disease (AD) patients treated with the monoclonal antibodies lecanemab and aducanumab compare with background mortality rates.  M...

Excess Mortality in Alzheimer’s Patients on Anti-Aβ Monoclonal Antibodies

www.researchsquare.com/article/rs-5...

[A preprint, not yet peer-reviewed]

#aducanumab #lecanemab #FDA #FAERS mortality #Alzheimer

Major lapses in FDA protocol found in 18-month #Aducanumab Congressional Inquiry:
•Over 50 non-official FDA-Biogen meetings
•Sidelining dissenting members of the FDA’s own statistical team
•Abrupt change from traditional to “accelerated...

2/5 With the great news coming yesterday from @EisaiUS and @bioarcticab regarding #lecanemab and controversy with @biogen #aducanumab, we intend to contribute with a better estimation of the critical element for future prescribers/patients: the risk/benefit ratio of these drugs

3 opinion editorials in @JAMANeuro on the recent accelerated approval by @US_FDA of #aducanumab for the treatment of #Alzheimers . Really interesting to...

The controversial approval by the @US_FDA of the Alzheimer’s disease drug #Aducanumab is made even worse by the fact that its clinical trials excluded 92% of the potential patient population. A highly dangerous minimally helpful drug for 8% only?
https://ja.ma/2XgssFo

NEW in @STATnews with @StephenLatham @YaleBioethics:

Patient advocacy organizations and FDA drug approval: lessons from Aduhelm
#Aduhelm #aducanumab #patientadvocacy #patientadvocate #patientsoverprofits

With Aduhelm, is history repeating itself with another wi... In Alzheimer's disease (and any illness), what's needed a...

Interesting historical perspective on the route to #aducanumab for #Alzheimers. "The billions of dollars invested in the amyloid juggernaut may have made it too big to fail."

www.statnews.com/2021/07/09/aducanumab-hi... via @statnews

EMA evaluation of #Aducanumab for #Alzheimers: "Beneficial effects can be based on intermediate endpoints that are 'reasonably likely' to translate into clinical benefit, without directly measuring the clinical benefit." Can EMA do better than the...

“#Aducanumab should only be used in the early stages of dementia and may not work for everyone,” he said.
“It can also cause side-effects and these need to be carefully monitored with regular MRIs" A/Prof Woodward said

...

#aducanumab FDA approval is a turning point in #Alzheimer ‘s disease patients’ care. Being more intended for early-stage patients, powerful and sensitive diagnostic procedures such as @pixylmedical 's AI-empowered tools are thus...