On June 7, the Food and Drug Administration approved the first new treatment for Alzheimer’s disease in nearly 20 years.
The historic decision offers hope for a way to actively combat this horrific disease, but also spurs controversy from the scientific community that the drug has not yet shown enough effective trials to merit approval.
Manufactured by Biogen, Aduhelm is the first Alzheimer’s medicine to slow the worsening of the disease by targeting brain-destroying proteins known as beta-amyloids that destroy neurons and lead to dementia.
The drug is intended as treatment and is explicitly not a cure, nor does it not reverse the progression of the illness.
In 2019, Biogen ceased trials of the medication after early data concluded that it was unlikely to work, but the manufacturer remained committed and announced that it would seek regulatory approval for the drug anyway.
In November 2020, outside advisers to the FDA concluded that the data behind the drug wasn’t substantial enough for a positive review and strongly objected to approval.
The FDA granted conditional approval for Aduhelm, based on the drug’s ability to clear beta-amyloids, but the manufacturer Biogen must still complete a large clinical trial confirming any possible cognitive benefits from removing these proteins.
If the results prove to be discouraging, the FDA can rescind its approval.
Caleb Alexander, a Johns Hopkins epidemiologist and a member of the FDA advisory panel that objected to Aduhelm’s approval, believes the approval focused more on meeting the need for an Alzheimer's drug, rather than diligently testing to ensure it’s ready for the public.
“The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards. It’s hard to find any scientist who thinks the data are persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold,” he said.
Many doctors and Alzheimer’s experts are hopeful on the drug’s potential treatment but want to ensure that patients and physicians are educated that the drug is not the end all be all, or a cure.
Additionally, in order to be approved for treatment with Aduhelm, patients must complete high-priced brain scans to be granted eligibility. Once granted, patients must receive the drug monthly through an intravenous infusion at a doctor’s office or health care facility.
According to Biogen, the yearly cost for a maintenance dose of Aduhelm would be $56,000, but the out-of-pocket cost for patients with insurance will vary. Analysts originally believed it would cost between $10,000 and $25,000 per year.
The hefty price tag resulted in heavy criticism considering the drug has not yet been proven completely effective.