Post by icemandios on Dec 21, 2021 16:57:14 GMT
December 21, 2021 10:15 AM ESTUpdated 10:37 AM PharmaFDA+
Alzheimer's experts call on FDA to pull Biogen's Aduhelm
Zachary Brennan
Senior Editor
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
“An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,” they wrote to FDA, explaining how Aduhelm “did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.”
Aaron Kesselheim
The battle over the Aduhelm approval has been brewing since the FDA’s adcomm voted almost unanimously against approval. Two of the members of that committee, Harvard’s Aaron Kesselheim (who later resigned from the committee) and Johns Hopkins’ Caleb Alexander are part of this group now advocating for Aduhelm to be pulled by FDA.
“In two prematurely terminated trials, one showed no effect, while the other showed an effect that was not clinically meaningful,” they wrote. “The FDA’s decision to approve Aduhelm is indefensible in both scientific and clinical terms. This drug should be withdrawn from the market immediately.”
The group of experts also includes Sam Gandy, professor of neurology at Icahn School of Medicine at Mount Sinai; Peter Whitehouse, professor of neurology at Case Western Reserve University; Lon Schneider, professor of psychiatry and neuroscience at USC; and Robert Howard, professor of old age psychiatry at University College London.
Caleb Alexander
Ever since the June approval for Aduhelm, Biogen has been backtracking.
First, Biogen narrowed the label for its infusion after the FDA approved the drug with a wide label for anyone with the debilitating disease.
After just $300,000 in early sales, mostly due to insurers declining to cover the drug ahead of CMS, the company has decided to reduce the price significantly.
And while a Biogen spokesperson said the company did not work with CMS or inform CMS of its decision to lower the price of Aduhelm ahead of time, the announcement was unveiled just three weeks before CMS’ major decision, and shortly after CMS decided to raise seniors’ premiums to historic new levels in order to plan for paying for Aduhelm.
Rachel Sachs
“Biogen has had months of pressure from multiple sources to make this price change, so to do it now when it might be too late to matter to seniors, was a choice,” Rachel Sachs, a professor of law who focuses on innovation policy at Washington University in St. Louis, told Endpoints News. She was unaffiliated with the statement to pull Aduhelm.
What’s more, the FDA is still investigating a death of an Aduhelm patient, and the group of experts noted that “the risks of Aduhelm are unacceptable. This drug causes high rates of potentially dangerous side effects (disorientation, falling, brain swelling and bleeding) and a risk of death that is yet to be defined.”
They also explained how FDA’s acceptance of amyloid plaque PET scans “instead of actual patient improvement for approving drugs for Alzheimer’s disease is not scientifically well-founded,” adding:
In the absence of clear evidence of meaningful clinical benefit, the continued availability of Aduhelm is likely to lead to widespread overtreatment that will not improve the quality of life of patients, will expose them to unnecessary harms, and will consume extensive resources better spent on supportive services and public health measures to help people with this potentially devastating disease.
Alzheimer's experts call on FDA to pull Biogen's Aduhelm
Zachary Brennan
Senior Editor
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
“An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,” they wrote to FDA, explaining how Aduhelm “did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.”
Aaron Kesselheim
The battle over the Aduhelm approval has been brewing since the FDA’s adcomm voted almost unanimously against approval. Two of the members of that committee, Harvard’s Aaron Kesselheim (who later resigned from the committee) and Johns Hopkins’ Caleb Alexander are part of this group now advocating for Aduhelm to be pulled by FDA.
“In two prematurely terminated trials, one showed no effect, while the other showed an effect that was not clinically meaningful,” they wrote. “The FDA’s decision to approve Aduhelm is indefensible in both scientific and clinical terms. This drug should be withdrawn from the market immediately.”
The group of experts also includes Sam Gandy, professor of neurology at Icahn School of Medicine at Mount Sinai; Peter Whitehouse, professor of neurology at Case Western Reserve University; Lon Schneider, professor of psychiatry and neuroscience at USC; and Robert Howard, professor of old age psychiatry at University College London.
Caleb Alexander
Ever since the June approval for Aduhelm, Biogen has been backtracking.
First, Biogen narrowed the label for its infusion after the FDA approved the drug with a wide label for anyone with the debilitating disease.
After just $300,000 in early sales, mostly due to insurers declining to cover the drug ahead of CMS, the company has decided to reduce the price significantly.
And while a Biogen spokesperson said the company did not work with CMS or inform CMS of its decision to lower the price of Aduhelm ahead of time, the announcement was unveiled just three weeks before CMS’ major decision, and shortly after CMS decided to raise seniors’ premiums to historic new levels in order to plan for paying for Aduhelm.
Rachel Sachs
“Biogen has had months of pressure from multiple sources to make this price change, so to do it now when it might be too late to matter to seniors, was a choice,” Rachel Sachs, a professor of law who focuses on innovation policy at Washington University in St. Louis, told Endpoints News. She was unaffiliated with the statement to pull Aduhelm.
What’s more, the FDA is still investigating a death of an Aduhelm patient, and the group of experts noted that “the risks of Aduhelm are unacceptable. This drug causes high rates of potentially dangerous side effects (disorientation, falling, brain swelling and bleeding) and a risk of death that is yet to be defined.”
They also explained how FDA’s acceptance of amyloid plaque PET scans “instead of actual patient improvement for approving drugs for Alzheimer’s disease is not scientifically well-founded,” adding:
In the absence of clear evidence of meaningful clinical benefit, the continued availability of Aduhelm is likely to lead to widespread overtreatment that will not improve the quality of life of patients, will expose them to unnecessary harms, and will consume extensive resources better spent on supportive services and public health measures to help people with this potentially devastating disease.