A new drug has been approved for Alzheimer's disease, but not everyone suffering from the progressive disease will potentially benefit from the use of the drug, and some are calling its approval controversial.
The drug Aducanumab (which is also known as Aduhelm) is the first therapy for Alzheimer's disease to be approved by the FDA since 2003. The drug was developed to be used by patients with mild cognitive impairment, and not those with severe dementia.
The FDA says the drug is meant to slow the progression of the disease and not just ease symptoms of Alzheimer's. "Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia," the FDA said.
The drug's approval comes with some controversy, as last year an FDA advisory committee concluded there was not enough evidence to support the drug's effectiveness.
"We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy," the FDA said. Adding, "If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm."
The cost of the drug, which is delivered as an infusion, is currently $4,312 per infusion, which a patient would get once every 4 weeks. The makers of the drug, Biogen and Eisai, noted these costs could be reduced down to zero for some, saying, "For qualified, commercially insured ADUHELM patients, co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0. Patients who are covered by Medicare through a Medicare Advantage plan have a maximum annual out-of-pocket cap."
CNN reports the FDA says patients must undergo an MRI before initiating treatment with Aducanumab and further MRIs are needed before the 7th and 12th infusion to check for brain abnormalities like bleeding in the brain.
Dr. Babak Tousi, who led a clinical trial at the Cleveland Clinic's Lou Ruvo Center for Brain Health tells CNN, "This treatment is very different than what we have had before. We have never had a medication that would slow down Alzheimer's disease progression. Current available medication such as donepezil or memantine only help modestly with the symptoms but do not slow down the disease's progression."