What you need to know about the new FDA-approved Alzheimer's drug
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The US Food and Drug Administration (FDA) recently granted conditional approval of a new treatment for people with early Alzheimer’s disease – it’s one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.
But the approval of this drug isn't as simple as it may appear. This new treatment has been subject to much scrutiny, with questions being raised about its efficacy, real-world value, and safety.
Lecanemab, an antibody-based drug jointly developed by pharmaceutical companies Biogen and Eisai, has officially been approved for use. The drug was previously found to reduce markers of amyloid beta, or the protein naturally found in the body that causes Alzheimer’s disease. The patients with early-onset Alzheimer’s who took lecanemab appeared to have a slowed down rate of cognitive decline as opposed to those who took a placebo.
The ‘historic’ clinical trials enrolled roughly 1,800 patients with early-stage Alzheimer’s. The patients were then given twice-a-week infusions of the drug, and the phase 3 clinical trials took place over the span of 18 months.
In November last year, The New England Journal of Medicine showed that lecanemab reduced toxic plaques in the brain. Around a fifth of the patients experienced side effects, including brain swelling or brain bleeding. Some 3 per cent of those patients experienced symptomatic side effects.
Dr Billy Dunn, the Director of the Office of Neuroscience in the FDA’s Centre for Drug Evaluation and Research, said in a press statement: ‘This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.’
This accelerated approval came amid reports that three deaths have occurred during the drug’s clinical trials. The clinical trial’s sponsor, Japanese biotech Eisai Co., did not divulge the fatality at a major Alzheimer’s meeting last month. The same meeting was where lecanemab’s phase 3 trial data was detailed to experts.
It also comes after Swiss pharmaceutical company Roche announced the failure of their experimental drug, gantenerumab, during its phase 3 trials. You can read more on that here.
Additionally, based on the trial data, lecanemab might only give people three to five months of improved cognition – at best. Some experts have even argued that patients and doctors alike are unlikely to see ‘noticeable’ changes at all.
Dr Sarah Kremen, Associate Professor of Neurology at the Jona Goldrich Centre for Alzheimer’s and Memory Disorders, said that in terms of risk, lecanemab faces similar consequences with drugs that did not make it to approval.
‘And there’s also risks that you would typically find—perhaps an increased risk of bleeding if somebody is taking a blood thinner already. So, these are things that we have to look out for,’ she added.
Lecanemab, which will be sold as Leqembi, isn’t the first anti-amyloid drug to be approved by the FDA. In 2021, the FDA also approved the drug Aduhelm, whose trial data seemed even more ambiguous than lecanemab. Aduhelm, which is the brand name for the medication aducanumab, was also developed by Biogen and Eisai.
The drug was originally set at US $56,000 (or AU $80,737) per patient per year, but in the wake of its approval, many accused the agency of pushing through a ‘worthless’ drug.
Now, the set price will be at US $26,500 per year (AU$36,787). Doctors also openly refused the prescription of Aduhelm, and Medicare ruled it would not cover the drug until clear evidence of its benefits was collected and presented.
At the end of December last year, a congressional report found that the FDA ‘skirted its own rules’ and was found to have an ‘atypical’ and close relationship with Biogen throughout the drugs’ approval process.
The investigation found that the FDA and Biogen engaged in ‘at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020’ – all to guide the potential approval of Aduhelm.
‘There was a strange dynamic compared to the other advisory committee meetings I’ve attended,’ said Dr Aaron Kesselheim, who is a Professor at Harvard Medical School and a former FDA adviser.
‘Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug,’ he added.
When Aduhelm was approved, Dr Kesselheim and two more members of the advisory committee resigned in protest. He called the drug ‘possibly the worst drug approval decision’ in US history.
In Australia, the Therapeutic Goods Administration (TGA) is more cautious in terms of approving drugs without strong evidence of the benefits. The FDA approval for lecanemab does not mean that the TGA will follow. Aduhelm is still currently under review by the TGA.
However, the Australian Dementia Network has set up a volunteer registration for people who’d like to participate in clinical trials, using lecanemab. You can find the link to that here.
Lecanemab is currently unavailable in Australia, but discretion should always be exercised when considering any kind of medical treatment. Make sure to consult with your doctor regularly before trying anything!
But the approval of this drug isn't as simple as it may appear. This new treatment has been subject to much scrutiny, with questions being raised about its efficacy, real-world value, and safety.
Lecanemab, an antibody-based drug jointly developed by pharmaceutical companies Biogen and Eisai, has officially been approved for use. The drug was previously found to reduce markers of amyloid beta, or the protein naturally found in the body that causes Alzheimer’s disease. The patients with early-onset Alzheimer’s who took lecanemab appeared to have a slowed down rate of cognitive decline as opposed to those who took a placebo.
The ‘historic’ clinical trials enrolled roughly 1,800 patients with early-stage Alzheimer’s. The patients were then given twice-a-week infusions of the drug, and the phase 3 clinical trials took place over the span of 18 months.
In November last year, The New England Journal of Medicine showed that lecanemab reduced toxic plaques in the brain. Around a fifth of the patients experienced side effects, including brain swelling or brain bleeding. Some 3 per cent of those patients experienced symptomatic side effects.
Lecanemab targets the proteins found in the body that’s found to be the cause of Alzheimer’s. Credit: Pixabay/Pexels
Dr Billy Dunn, the Director of the Office of Neuroscience in the FDA’s Centre for Drug Evaluation and Research, said in a press statement: ‘This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.’
This accelerated approval came amid reports that three deaths have occurred during the drug’s clinical trials. The clinical trial’s sponsor, Japanese biotech Eisai Co., did not divulge the fatality at a major Alzheimer’s meeting last month. The same meeting was where lecanemab’s phase 3 trial data was detailed to experts.
It also comes after Swiss pharmaceutical company Roche announced the failure of their experimental drug, gantenerumab, during its phase 3 trials. You can read more on that here.
Additionally, based on the trial data, lecanemab might only give people three to five months of improved cognition – at best. Some experts have even argued that patients and doctors alike are unlikely to see ‘noticeable’ changes at all.
Dr Sarah Kremen, Associate Professor of Neurology at the Jona Goldrich Centre for Alzheimer’s and Memory Disorders, said that in terms of risk, lecanemab faces similar consequences with drugs that did not make it to approval.
‘And there’s also risks that you would typically find—perhaps an increased risk of bleeding if somebody is taking a blood thinner already. So, these are things that we have to look out for,’ she added.
Alzheimer’s disease currently has no cure. Credit: Anna Shvets/Pexels
Lecanemab, which will be sold as Leqembi, isn’t the first anti-amyloid drug to be approved by the FDA. In 2021, the FDA also approved the drug Aduhelm, whose trial data seemed even more ambiguous than lecanemab. Aduhelm, which is the brand name for the medication aducanumab, was also developed by Biogen and Eisai.
The drug was originally set at US $56,000 (or AU $80,737) per patient per year, but in the wake of its approval, many accused the agency of pushing through a ‘worthless’ drug.
Now, the set price will be at US $26,500 per year (AU$36,787). Doctors also openly refused the prescription of Aduhelm, and Medicare ruled it would not cover the drug until clear evidence of its benefits was collected and presented.
At the end of December last year, a congressional report found that the FDA ‘skirted its own rules’ and was found to have an ‘atypical’ and close relationship with Biogen throughout the drugs’ approval process.
The investigation found that the FDA and Biogen engaged in ‘at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020’ – all to guide the potential approval of Aduhelm.
‘There was a strange dynamic compared to the other advisory committee meetings I’ve attended,’ said Dr Aaron Kesselheim, who is a Professor at Harvard Medical School and a former FDA adviser.
‘Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug,’ he added.
When Aduhelm was approved, Dr Kesselheim and two more members of the advisory committee resigned in protest. He called the drug ‘possibly the worst drug approval decision’ in US history.
In Australia, the Therapeutic Goods Administration (TGA) is more cautious in terms of approving drugs without strong evidence of the benefits. The FDA approval for lecanemab does not mean that the TGA will follow. Aduhelm is still currently under review by the TGA.
However, the Australian Dementia Network has set up a volunteer registration for people who’d like to participate in clinical trials, using lecanemab. You can find the link to that here.
