The first dose of the breakthrough, yet controversial, drug to treat Alzheimer’s disease took place Wednesday morning marking a pivotal turn in the fight against the disease. The Food and Drug Administration (FDA) approved Aduhelm, which is manufactured by Biogen, on June 7 to help treat the six million Americans suffering from Alzheimer’s.
The Michigan Institute for Neurological Disorders (MIND) announced it was the very first in the country to administer Aduhelm, which is targeted for patients with mild cognitive impairment or early Alzheimer’s disease.
The first patient, a 68-year-old woman from West Bloomfield, Mich., said the drug gives her hope.
“While I feel like I’m functioning just fine now, my prognosis tells me that I can expect changes in the future,” she said. “I do know that I want to be able to preserve myself, my cognitive abilities, as long as possible and if I can help others by being one of the first to experience this new treatment option, I’m excited to do so for the greater good. It’s a glimmer of hope for me and others.”
The Alzheimer’s Association issued a news release about the novel drug, saying that Aduhelm, the brand name for aducanumab, is an FDA-approved therapy to potentially delay decline from the disease, compared to current medications that only address symptoms.
The association explains that the drug is the first form of therapy that removes amyloid plaque from the brain, which may delay progression of the disease.
“While this drug is not a cure, it’s certainly a step in the right direction and offers hope for patients,” said Dr. Jonathan Fellows, neurologist and co-director of MIND’s Alzheimer’s Disease and Memory Disorder Center. “If we can slow the progression of Alzheimer’s disease, our patients may be able to benefit from future treatments as they become available.”
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease because it targets the fundamental pathophysiology of the disease. It is also the first new treatment approved for Alzheimer’s since 2003.
The drug, which is administered intravenously, is a lab-made antibody that attacks small and large clumps of the sticky protein amyloid beta. Research indicates the treatment works by slowing disease progression by removing amyloid beta proteins from the brain–a telltale feature of Alzheimer’s disease.
Aduhelm was approved using the accelerated approval pathway, which is typically used when a drug for a serious or life-threatening illness is found to have a meaningful therapeutic advantage over existing treatments.
The drug is administered intravenously at hospitals and infusion therapy centers for 45 to 60 minutes every four weeks, according to the Alzheimer’s Association. The most common side effects in clinical trials were abnormal brain changes ― mostly swelling in the brain ― headaches, and minor bleeding.
While some experts herald the approval of Aduhelm, others say that its exorbitant cost makes it prohibitive for many Americans. The infusions cost $56,000 annually, not including the price of MRIs, PET scans, and facility fees associated with the procedure.
Since most Alzheimer’s patients are eligible for Medicare, experts predict that approving the drug may cost the federal government $112 billion annually.
The Alzheimer’s Association advises anyone who is experiencing memory changes to consult with their physician to see if Aduhelm may be a treatment option.
© 2021 NewsmaxHealth. All rights reserved.