Aducanumab Not A Cure For Alzheimer’s Disease
Alzheimer’s disease and other forms of dementia are the fastest-growing cause of death on the planet. It’s the only major cause of death that evades effective treatment, which means that there is not a cure.
Pharmaceutical companies have spent years of research and billions of dollars trying to find effective treatments, if not cures, for Alzheimer’s disease. They all have failed. Fortunately, a new class of pharmaceutical intervention offers hope of treatment. Unfortunately, the new frontier of treatment is not a silver bullet and it is expensive.
The U.S. Food and Drug Administration conditionally approved the first treatment of Alzheimer’s disease in nearly two decades. After a lengthy development process, two large studies offered conflicting evidence about whether Biogen’s aducanumab treatment slows the erosion of neurodegenerative disease.
This is the first approved Alzheimer’s disease drug that treats a cause of the disease rather than just symptoms.
Despite the important progress, the new drug is not a cure and it doesn’t have universal support among experts. At best it will ease symptoms, improve functionality and slow the progression of the brain damage.
Aducanumab works by removing sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer’s disease. The drug also should offer similar benefits to those who have Parkinson’s disease, but the company has not commented on that potential application, yet. (The main difference between Alzheimer’s disease and Parkinson’s disease is the region of the brain that is being smothered by plaque.)
Biogen acquired the development and marketing rights from Neurimmune Therapeutics in 2007. A small clinical study found that the drug cut brain plaque levels and significantly improved cognition.
In a small study in 2015, aducanumab showed promise as the first experimental Alzheimer’s disease treatment to significantly slow cognitive decline and reduce brain-damaging plaque in patients with early and mild forms of the disease.
Later that year, Biogen found that the drug’s 10-milligram dose produced high rates of brain swelling. Meanwhile, a smaller six-milligram dose of aducanumab failed to significantly slow mental decline.
In 2019, Biogen ended two late-stage trials for aducanumab after an independent data monitoring committee found that the drug was unlikely to be successful. Despite the setback, Biogen revived plans to seek U.S. approval for aducanumab, saying data from more patients in two discontinued studies showed that the drug slowed progression of Alzheimer’s disease. Biogen said new analysis of more data from the trials showed that one of the studies met the main goal, while the other did not.
In 2020, Biogen submitted an application seeking U.S. FDA approval of aducanumab. The FDA conducted an expedited review of the drug. In November 2020, FDA staff said Biogen showed “exceptionally persuasive” evidence that aducanumab is effective. However, a panel of outside advisers disagreed with the FDA and claimed that aducanumab has not been proven to slow progression of the disease. The FDA extended the review period for aducanumab by three months, which concluded with yesterday’s approval.
As a condition of approval, the FDA is requiring Biogen to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn’t show a clinical improvement, the agency could move to withdraw the approval.
“The FDA concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” said Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research.
It could take several years to conclude the clinical trials the FDA is requiring. But in the meantime, Aduhelm will be available to patients.
Patients will receive the drug in monthly infusions. They will also need regular brain scans to detect a rare side effect: bleeding or swelling in the brain.
“This is good news for patients with Alzheimer’s disease. We’ve not had a disease modifying therapy approved ever,” said Dr. Ronald Petersen, a neurologist at the Mayo Clinic. “This is not a cure. Hopefully, it will slow the progression of the disease.”
Treating Alzheimer’s disease with aducanumab requires a monthly injection. Biogen will market the drug as Aduhelm. It will cost patients $56,000 per year. Health insurance companies will likely balk at reimbursements.
An independent think tank assessed the two phase 3 clinical trials of aducanumab and found the evidence “insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.
Dr. Jason Karlawish, professor of medicine and medical ethics and an Alzheimer’s expert at the University of Pennsylvania’s Perelman School of Medicine, wrote last week that he would not prescribe aducanumab to his patients even with FDA approval, due to risks of small bleeds in the brain, financial cost and unclear benefits.
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Gary Chandler is a prion expert. He is the CEO of Crossbow Communications, author of several books and producer of documentaries about health and environmental issues around the world. Chandler is connecting the dots to the global surge in prion disease, including Alzheimer’s disease, Parkinson’s disease, Creutzfeldt-Jakob disease, chronic wasting disease. The scientific name for prion disease is transmissible spongiform encephalopathy.