Aduhelm® (Aducanumab) was approved by the FDA on June 7, 2021, for the treatment of Alzheimer’s disease. To learn more about Aduhelm please click here.
Aduhelm® (Aducanumab) was approved by the Food and Drug Administration (FDA) on June 7, 2021. It is the first medication approved by the FDA for slowing the progression of Alzheimer’s disease. However, there are some concerns with the study results upon which the decision to approve was made, said Herman Sullivan, MD, executive medical director, Hauenstein Neurosciences and medical director of the Multiple Sclerosis Clinic at Mercy Health Saint Mary’s.
“Not every patient with Alzheimer’s will get this drug,” Dr. Sullivan said. “There are restrictions on who should get it. Patients with mild evidence of the disease could receive it but we have no evidence that it helps patients with moderate to severe Alzheimer’s since they were excluded from the study at enrollment.”
“We anticipate prescribing Aduhelm for certain patients once we have further guidance on appropriate pre-requisite testing prior to using the drug and verification on insurance coverage,” Sullivan added.
Aduhelm received accelerated approval for its ability to reduce the levels of amyloid protein deposited in the brain as plaques, but not for its ability to slow Alzheimer’s. This effect on the amyloid deposition was seen in a small number of selected patients who received a higher dose in one of the studies.
“This drug failed the gold standard testing,” said Dr. Sullivan. “Aduhelm has a biological effect – it removes amyloid and prevents deposition. But the clinical effect has not been verified with a confirming second study. It’s like prescribing a drug that will bring your blood pressure down but has no evidence it will decrease the risk of a stroke, heart attack, or kidney disease. So, the question is – will you benefit from being on the drug? Right now, we have more evidence that you will not.”
Additionally, there are safety concerns with the use of the drug. Approximately 40-percent of patients in testing developed ARIA (amyloid related imaging abnormalities), a type of brain swelling with and without small brain hemorrhages in an already injured brain due to the Alzheimer’s disease itself.
Given this, it is appropriate for practitioners and patients to proceed with due caution when prescribing and receiving this drug.
“There is a safety issue. There are concerns about other effects but based on the biological measure that it reduces amyloid deposition; the FDA overruled the Advisory Committee’s recommendation and said, ‘We’re going to approve your drug.’ To me, there is not substantial clinical evidence to approve it for use,” said Sullivan.
Furthermore, the FDA has requested that Biogen conduct another study to show safety and efficacy – the kind of study that should be done prior to approval. Biogen is to complete the study within nine years. It is possible that this study will show that Aduhelm does not work.
The cost of Aduhelm will be extremely expensive and prohibitive as well.
“It’s not the most expensive drug but the added costs of monitoring scans, preliminary screening and duration of treatment, all add up,” said Sullivan. “The yearly cost for drug utilization will be quite hefty.”
Mercy Health is reviewing more information to determine how to best implement this medication into practice. Clinics will not be able to widely dispense the medication until Medicare, Medicaid and third-party payer requirements for coverage are known. Only then will it be available on a limited basis.