ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review):
The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms.
Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients. The avenue forward has seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects.
However, instead of waiting for such a trial, the FDA chose to move the goalposts and approve aducanumab based on the surrogate outcome of removing amyloid from the brain rather than the patient-centered outcome of Clinical Benefit, which has been required of all previous emerging treatments for Alzheimer’s disease. Many other drugs have been shown to remove amyloid from the brain, yet have failed to help patients, making this decision all the more puzzling. Keep reading the important statement HERE, over at ICER website.
The Announcement:
FDA Grants Accelerated Approval for Alzheimer’s Drug (press release):
Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit … Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s disease are not fully known, it is characterized by changes in the brain—including amyloid plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember and think.
… The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms, though some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea. Another warning for Aduhelm is for a risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.
Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
News in Context:
- Three members of the FDA advisory committee have already resigned in protest. Here’s their reasoning: Joel Perlmutter, David Knopman and Aaron Kesselheim.
- What does a clear majority of the biopharma industry think of the FDA approval of aducanumab? ‘Horrifying’ ‘Dangerous’ ‘Confusing’ ‘Disaster’
- ‘Simply unacceptable’: Alzheimer’s Association blasts Biogen over the price of its new medicine
- Study challenges the “seductive” amyloid hypothesis of Alzheimer’s disease (AD)
- Brain scans show lower accumulation of tau and amyloid pathology among cognitive “super-agers”
- Cognitive training, diet, exercise, and vascular management seen to improve cognition even in people with genetic predisposition for dementia (APOE e4)
- Report: 35% of worldwide dementia cases could be prevented by modifying these 9 modifiable risk factors
- From Wikipedia: On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock’s position as Acting Commissioner of the FDA. The letter said in part that “as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history.”[Examples of improper opioid decisions mentioned in the letter include “approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11–2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years old.”
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