The U.S. Food and Drug Administration has granted “accelerated approval” for a new drug for Alzheimer’s disease in nearly two decades.
The drug, Aduhelm (aducanumab), is reported to be a monthly intravenous infusion that is geared towards slowing the cognitive decline of patients with mild memory and thinking problems. It is the first treatment for Alzheimer’s that has been approved since 2003 for its ability to clear the toxic proteins, called beta-amyloid, after it was tested in two late-stage human trials known as Phase 3 trials; however, it must be noted that there was not enough evidence found that the drug can help patients suffering from the disease.
The FDA required that manufacturer Biogen conduct a new clinical trial, a Phase 4 trial, to prove its efficacy and the cognitive benefits of removing the beta-amyloid. If the study fails, the FDA can, but is not required to, take back its approval.
Also affecting the FDA’s decision to grant marketing clearance for this drug was the public’s desperate need for new treatments.
“Now we have a potential treatment for them that may modify the underlying disease course. But the largest responsibility for us is to educate patients and physicians as to what this means. This is not going to be penicillin for Alzheimer’s disease,” said Ronald Petersen, a neurologist of the Mayo Clinic Alzheimer’s Disease Research Center.
The yearly cost of treatment will be priced at US$56,000. Biogen is scheduled to ship the drug out within the next two weeks. Note that it is not a cure for Alzheimer’s and will not reverse its progression.
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