While other drugs treat symptoms of Alzheimer's, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. It does so by eliminating clumps of a toxic protein believed to destroy neurons and cause dementia. Aduhelm is not a cure for Alzheimer's, and it doesn't reverse the disease's progression.
Acuranumab, marketed as Aduhelm, is a monthly intravenous infusion. It is designed to halt the cognitive decline in adults with mild memory and thinking impairments. It is the first FDA-approved medication for Alzheimer's disease that targets the disease process rather than just the symptoms.
How does the Alzheimer’s drug work?
Aduhelm is the first drug to target the disease's core cause and reduce cognitive deterioration, but only minimally. Aduhelm isn't a cure for Alzheimer's disease, and it doesn't stop it from progressing.
Acuranumab (Aduhelm), a novel medication, is a monoclonal antibody that prevents the formation of amyloid plaques in the brain. Memory loss and eventually the inability to execute simple actions like clothing oneself are caused by these plaques.
The treatments cost approximately $56,000 a year, according to Biogen. Lon Schneider, MD, director of the California Alzheimer Disease Center, said that amount is unlikely to be paid. Biogen guaranteed a variety of options for patients to obtain the medicine by Tuesday morning. According to the company, service coordinators will be available to provide one-on-one assistance.
Is the Drug meant for all people with Alzheimer's?
According to Julia Biernot, MD, a behavioral neurologist at the University of Maryland School of Medicine in Baltimore, the new medicine is not for everyone with Alzheimer's. "It's important to know that it is most likely going to be indicated in patients who have mild Alzheimer's disease or mild cognitive impairment, as opposed to more advanced disease."
According to Biogen, the most prevalent is a disorder known as ARIA. Amyloid-related imaging abnormalities or ARIA was detected in 41% of patients in one research. These issues include transient brain swelling and tiny bleeding spots.
When and where will it be available to patients?
Biogen intends to start shipping products in approximately two weeks. And has more than 900 facilities across the US expected to be ready to do so, according to the firm. Every four weeks, the medicine will be given as an intravenous infusion lasting about an hour. According to Aburashed, Memorial Healthcare in Michigan has an infusion center where the treatment can be provided.
What are some of the possible side effects?
The prescribing information for Aducanumab warns of "amyloid-related imaging abnormalities," or ARIA, which can be observed on magnetic resonance imaging (MRI) scans as brain swelling or episodes of brain bleeding. Acuranumab can also cause headaches, dizziness, diarrhea, and confusion, delirium, or disorientation.
"ARIA seems to occur early in treatment during the first 12 weeks, 16 weeks or so," Schneider said, adding that persons who have a variant of the apolipoprotein gene known as APOE4 — a risk factor for Alzheimer's disease — seemed to be at higher risk of such occurrences.
FDA's Accelerated Approval
The FDA granted expedited approval based on a clinical trial that indicated that people who received the medicine had less plaque in their brains than those who received control or placebo. The FDA granted the approval after reviewing three distinct trials involving almost 3,500 individuals.
Many people were surprised by the decision considering the FDA's own advisory group voted 8 to 1 against approving the medicine last November, citing a lack of convincing proof that it works. According to STAT, one member of the advisory board resigned as a result of the FDA ruling.
Schneider explains, "The FDA authorized this based on the antibody lowering amyloid plaques." However, he points out that lowering the plaque does not prove that there is a clinical advantage, such as reducing memory loss.
Biogen and Eisai, the medicine's manufacturers, must conduct ongoing research to ensure that the medicine has a clinical benefit. If the results of this new trial do not reveal a benefit, the FDA will take action.
What is the controversy around the drug?
The road to approval for the drug hasn't been easy. Acuranumab was on the verge of being canceled in 2019 after failing in two large clinical trials. The medicine's developer, Biogen, is located in Cambridge, Mass. They discovered evidence that the treatment might work after all after reanalyzing new data that came in later and decided to pursue FDA approval.
Nonetheless, some doctors and scientists are concerned about this decision, believing that the FDA's action is premature because they aren't persuaded that the treatment, also known as Aduhelm, genuinely works. Those specialists warn that approving a medicine that isn't effective will set back Alzheimer's research and give patients false hope.
What other Alzheimer's therapies are available?
While aducanumab is the first of its kind, other medications to treat Alzheimer's disease symptoms have been around for a while.
The medicine donepezil was licensed in the United States in 1996 and is still widely used to treat Alzheimer's disease. It and other related medications can help improve brain function, but they can't stop mental abilities from deteriorating over time.
Donepezil and similar drugs, such as galantamine and rivastigmine, are cholinesterase inhibitors that are generally recommended for mild to moderate Alzheimer's disease. Memantine, also known as Namenda, is a medicine used to treat the symptoms of Alzheimer's disease in people who have moderate to severe Alzheimer's disease.