FDA Approval of New Alzheimer's Drug Offers Hope
In what many hope to be a new frontier for Alzheimer’s research and treatment, the FDA recently approved the use of aducanumab (brand name Aduhelm) for treatment of patients with Alzheimer’s disease. The drug, approved on June 7, 2021, is the first of its kind marketed to slow progression of the brain disease; other existing drugs only help manage the symptoms. The last time the FDA approved an Alzheimer’s drug was 2003.
Aducanumab is intended to work by reducing the level of amyloid plaques in the brain, which may contribute to the cognitive decline associated with Alzheimer’s.
“Any advance in treatment science for Alzheimer’s is a reason for hope for so many people living with dementia and their families and for that reason—this is big news,” says Juliet Holt Klinger, Brookdale’s Senior Director, Dementia Care. “But I am cautiously optimistic and will be anxious to see the results of the post-approval clinical trial.”
The decision is not without controversy, as in November 2020, the FDA’s own panel of independent advisors concluded that even the strongest available clinical trial data did not support the drug’s effectiveness. The FDA has also required the drug’s maker, Biogen, to conduct a post-approval clinical trial. “If the trial fails to verify clinical benefit,” the FDA’s statement read, “the FDA may initiate proceedings to withdraw approval of the drug.” Biogen announced a new 24-month trial at the American Academy of Neurology’s annual meeting in April 2021.
Some experts are also concerned about the cost of the drug, which is administered in monthly infusions. The “list price”—which is set by a drug’s manufacturer but is only one of many factors in the price a consumer might pay—is $56,000 a year.
Amid the debate, the decision was celebrated by the Alzheimer’s Association, which posted a statement on its website that read, in part, “The historic approval of aducanumab ushers in an exciting era in Alzheimer’s and dementia treatment and research. Approvals of the first drug in a new category benefit people living with the disease by invigorating the field, increasing investments in treatments and generating innovation.” While Alzheimer’s experts may be somewhat divided on the specific drug and the FDA decision, there is overwhelming excitement for the idea that there may be hope for people with Alzheimer’s. Holt Klinger notes that the dialogue around the new drug further confirms the importance of making brain health part of your conversation with your physician.
“This drug, like others before it, is mostly useful if prescribed when dementia symptoms first begin to emerge,” she says. “Unfortunately, this is a time when many prefer the comfort of denial. Honest conversations with your physician may open up avenues to treatment if dementia is diagnosed early.”
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