Biogen's Aduhelm 'likely' linked to Alzheimer's patient's death, RBC analyst says | FiercePharma

[anonymous]

Biogen's Aduhelm 'likely' linked to Alzheimer's patient's death, RBC analyst says | FiercePharma


Biogen's Aduhelm 'likely' linked to Alzheimer's patient's death, RBC analyst says

 

[anonymous]

Another day, another body blow for Aduhell.

 

[anonymous]

"While VA PBM acknowledges the recent FDA decision on aducanumab-avwa, given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal, we recommend against offering this agent to patients with Alzheimer’s dementia (mild or otherwise) or mild cognitive impairment. However, recognizing that there is an accelerated Aducanumab Monograph Updated version may be found at PBM INTERnet or PBM INTRAnet FDA approval, we also recommend that if it is to be used by exception then it should be utilized only in highly selected patients by experts and centers that have the necessary diagnostic and management expertise— and only by those with the needed resources for close monitoring to assure safety. As such, any use should be governed by stringent regulation, and safety and appropriateness of use monitored real time by VAMedSAFE"

Primum non nocere

 

[anonymous]

Biogen
Their consumer product Aduhelm, is back in the news again and as usual, not for good reasons. Word is they're investigating the death of a 75 year-old who was taking it. Certainly at this point no one can claim to know if the product is at fault – people with Alzheimer’s tend to die for myriad reasons. And really it may be unprovable in any case.

But this reminds us of the original clinical data which showed unequivocally that side effects, including brain swelling, were a very real and potentially dangerous phenomenon while those same studies failed to show if the product made Alzheimer’s patient symptoms any better. The risk/reward profile was not something that would traditionally be considered approvable, and so here they are investigating a patient death.

If that wasn’t enough, the European Medicines Agency handed down a “negative trend vote” against Aduhelm. Sounds problematic, but recall the FDA advisory committee voted 10-0 against, and it still got approved in the US, so who the hell knows what will happen.

Oh and also Biogen's EVP of R&D decided to leave the company this week. Good times over there.

 

[anonymous]

The study titled “Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease"
was published online yesterday, November 22nd, 2021 in JAMA Neurology.

Key points in the study:

" Question What are the characteristics of amyloid-related imaging abnormalities (ARIA) during aducanumab treatment in individuals with early Alzheimer disease?

Findings In an integrated safety data set of 2 phase 3 clinical trials (EMERGE and ENGAGE) including 3285 participants, 425 patients (41.3%) in the combined 10 mg/kg aducanumab group (n = 1029) experienced ARIA; ARIA-edema occurred in 362 patients (35.2%), and 94 of these patients (26.0%) experienced associated symptoms (eg, headache, confusion, dizziness, and nausea). ARIA-microhemorrhage and ARIA–superficial siderosis occurred in 197 patients (19.1%) and 151 patients (14.7%), respectively.

Meaning Amyloid-related imaging abnormalities occurred in approximately 40% of participants in the phase 3 studies of aducanumab, and approximately one-quarter of these patients experienced symptoms."

These data and the patient death on Aduhelm following ARIA-E and ARIA-H suggests the FDA will require a black box warning in the Aduhelm label.

 

[anonymous]

Someone for the love of god end this madness already and pull this product. How many more articles, links, cafe pharma posts, need to dwell over this ridiculous topic.

This MEDICATION IS DEAD!!! PULL IT AND MOVE ON WITH YOUR LIVES