The Food and Drug Administration’s accelerated approval of Biogen’s drug to treat Alzheimer’s disease, is a significant step in the fight against the debilitating illness that destroys memory and other mental functions — but there’s still a long way to go, experts said.
Biogen Inc.’s BIIB, +38.34% drug, called aducanumab but under the name of Aduhelm, is the first treatment for Alzheimer’s to be approved since 2003, and is supposed to slow the progression of Alzheimer’s in patients with early symptoms. The medication is taken through a periodic injection. The full ramifications of this treatment, as well as its efficacy rate and side effects, are still unknown, however. Feedback from doctors and researchers have been mixed with optimism and criticism.
“Alzheimer’s is one of the most incredibly difficult diseases that we know of,” said Charbel Moussa, associate professor of neurology and head of the laboratory for dementia and Parkinsonism at Georgetown University. Researchers have studied the “ideology” of the disease over the last 18 years, but there is still so much more to understand about it, Moussa said. Research of the disease must be compartmentalized, to dig deeper into how the brain functions, why chemicals are not properly transmitted, the effects on activities of daily living (such as bathing and putting on clothes) and the quality of life for patients and their caregivers. “This approval right now is going to open Pandora’s box,” he said.
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More than six million people live with Alzheimer’s, according to the Alzheimer’s Association, and by 2050, that figure is expected to jump to nearly 13 million. In 2021, the costs associated with Alzheimer’s and other dementias are expected to be $355 billion, and by 2050, will rise to $1.1 trillion. Everyone is affected differently by Alzheimer’s, and the disease could begin in an individual as early as 20 years before symptoms, such as forgetfulness and language issues, are present.
Although an optimistic moment, the FDA’s approval is just one of the many hurdles drug companies face when developing a drug, and “approval doesn’t mean efficacy,” said John DenBoer, a doctor, chief executive officer of Smart Brain Aging and producer of the film “This is Dementia.” Many “anti-Alzheimer’s” drugs, as they are known, have failed, and more post-approval clinical trials must be conducted. It would take years for this medication to be distributed to the public, he said.
This treatment would not cure or partially reverse Alzheimer’s in any stage, either, DenBoer warned — those are unrealistic goals, at least for where researchers are in the fight against Alzheimer’s right now. “The best medication we have had at this point has shown an at-best 5% efficacy rate, and only in the very early stages of the disease,” he said. “If you can mitigate the intensity of this disease by 10% at the early stage, that would be really impactful and life-changing for many people, and I think that is a really admirable goal.”
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There are still many unknowns regarding this treatment. There is still uncertainty about payment and insurance coverage, though some patients may be charged $10,000 or more in out-of-pocket expenses, Moussa said. There are also concerns about side effects, such as delusions and confusion, or brain swelling from the injections, he added. “The benefit-risk ratio is a very important factor and has to be decided on an individual basis.”
Biogen, which has partnered with Japanese pharmaceutical company Eisai, estimated 1.5 million Americans would be eligible for this treatment, according to Reuters.
“Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit,” the FDA said in a statement. “If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”
While these questions await answers and trials continue, patients and loved ones with Alzheimer’s should look for natural ways to improve their cognitive state, including participating in aerobic and mental exercises, maintaining healthy relationships and getting out of the house, DenBoer said. Also be willing to have these conversations with primary care physicians, even if this is a sensitive topic. “Don’t put your trust in medications,” he said. “If a medication comes along that would really help, that would be amazing, but we can’t wait for it. Time is too precious.”
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