Controversial Alzheimer’s drug Aduhelm underwhelmed in early sales. Despite poor performance, some neurologists hope the drug will mean more new Alzheimer’s treatments — and more diverse approaches.
Analysts had high hopes for anti-amyloid drug Aduhelm — the first Alzheimer’s treatment approved by the FDA in nearly two decades and the first ever disease-modifying drug for the epidemic-scale neurodegenerative disease — projecting $14 million in sales between July and the end of September. But the unexpected controversy around the drug’s approval, which led to many clinics declining to offer the treatment, threw those estimates dramatically off course: So far, Aduhelm sales have only brought in $300,000 total.
“We are obviously disappointed with the delayed uptake of Aduhelm in the U.S.,” CEO of drugmaker Biogen Michel Vounatsos said on a conference call with investors. Biogen has also filed for approval in other countries and regions but has yet to receive approval.
Despite Aduhelm’s poor performance on the market, there is reason for optimism according to some experts in drug development. Dr. Donald Weaver, clinical neurologist, senior scientist, and director at Krembil Institute spoke with Being Patient about the direction of drug development in Alzheimer’s. In his research, Weaver develops new drugs with the potential to treat Alzheimer’s and dementia. His lab has developed two drug compounds that reached Phase 3 trials but failed to show efficacy.
Aduhelm’s approval to drive future Alzheimer’s drug development
Biogen, has another anti-amyloid therapeutic in its pipeline: lecanemab. But this class of treatments, termed “biologics,” are expensive to manufacture. Aduhelm comes with a prohibitive price tag, $56,000 per year; other antibody-based therapeutics, lecanemab included, are expected to come with similar price tags.
“We have not heard that price is the primary driver for any decision to treat patients,” Alisha Alaimo, Biogen’s president of U.S. organization said on an October conference call with investors. But some experts believe that even low levels of sales are good news for the future of Alzheimer’s drug development.
“Given the limitations of their compound, the fact that they got it approved is a good thing,” Weaver said of Biogen’s Aduhelm. “A lot of pharmaceutical companies are not into neuroscience, because the risks and the developmental costs are too high.”
Another issue with drugs like Aduhelm is that they may be introduced too late in the course of the disease. Weaver added that it may be most effective before the onset of Alzheimer’s symptoms, which is an enormous challenge because “there isn’t a good biomarker yet.”
More and more technologies and researchers focused on defining and detecting biomarkers early — people could soon receive a diagnosis a few years earlier, leading to better clinical outcomes.
The future of Alzheimer’s treatments
According to a 2015 article published in JAMA Neurology, by treating Alzheimer’s as one distinct disease, many clinical trials might be missing the mark on personalized treatments. Many people with Alzheimer’s already take a personalized regimen of six to 12 medications per day to manage their cognitive and memory decline, behavioral and mood changes, as well as other symptoms.
“I think it’s naive to think we’ll get the pill for Alzheimer’s,” Weaver said. “Moreover, we don’t know if Alzheimer’s is one disease or many separate entities.”
Weaver likens Alzheimer’s to blood pressure — another condition with many potential factors and causes. People take multiple different drugs to regulate their blood pressure, tailored to specific physiological issues. Due to the diversity of Alzheimer’s itself, it is likely that a combination of drugs is required for its treatment, tailored to the individual. The same combination of treatments may not work for two different individuals.
“I think there’s a role for anti-amyloid agents, a role for anti-tau agents, and a role for other agents as well,” Weaver said. Working with a physician in the future may involve monitoring different biomarkers and how they respond to a combination of different types of Alzheimer’s drugs.
According to Weaver, the high cost of biologics could lead to health disparities across different countries in the world. Other types of drugs developed as small molecules rather than complex antibodies might be the future. Weaver added:
“My hope is we get more than one small molecule [effective for treating Alzheimer’s], which is cheap enough to have a global impact.”