Japanese officials followed suit and denied the approval based on Phase 3 studies not proving Aducanumab’s medical benefit. According to the publicly available data, this treatment provided statistically significant benefit in slowing cognitive decline due to early Alzheimer’s. The company said discontinuing this drug was a business decision based on how it wants to allocate its resources. FDA is still keeping a watch on Biogen’s post-approval clinical trial in order to evaluate the drug’s clinical benefit against AD.
Explained: The new drug for Alzheimer’s disease
- A decision analytic model was used to estimate the lifetime health and economic outcomes of adults with early AD, from US healthcare sector and societal perspectives.
- Protecting state budgets shouldn’t require Medicare to cover an expensive drug with unproven clinical benefits, and Congress should take steps to fix this problem.
- For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf.
- It is vital to obtain a brain MRI before starting aducanumab, as ARIA may develop with treatment.
Aducanumab is a potentially promising treatment for the 6 million aducanumab price in india Americans with AD, most of whom are 65 years or older and eligible for Medicare. Our analysis suggests that aducanumab may not be cost‐effective at this price even though we modeled a best‐case scenario in which aducanumab completely halted AD progression. In our model, aducanumab met the WTP threshold of $100,000 when the price was decreased to $22,820 annually.
Controversy: Insufficient data to support efficacy
(6) Data supported by randomization indicating that the low dose in Study 301 was numerically superior to the high dose despite none of the participants having received the 10 mg/kg dose. (7) The distribution of regional enrollment changing over the course of the studies may have confounded the impact of PV4, allowing the ApoE+ high dose to reach 10 mg/kg instead of only 6 mg/kg in earlier protocols. The reviewers concluded that there was no convincing evidence from available data that there was a delay in clinical progression of cognitive or functional decline from these studies. They noted that the single positive timepoint was un-replicated and conflicted by the second study. Additionally, the delayed start design with termination for futility did not help with the completeness or interpretability of long-term follow-up data in these studies.
FDA press release
It’s recommended to begin treatment in patients experiencing mild cognitive impairment or in the early stages of dementia. Accelerated approval is for drugs that can help with serious illnesses but also need more study. Even though Aduhelm is available to people with Alzheimer’s disease whose doctors believe it will help (and can administer the infusions in their offices), another phase (Phase 4) of trials is still ongoing.
We hope that the drug proves its effectiveness and benefits the human race against Alzheimer’s Disease. “There are some hyped medicines and it could be possible that when tried on the ground they may not be useful. This narrative review did not include studies indexed in databases other than Google Scholar, Web of Science, and MEDLINE. Future AD management is likely to focus on passive immunotherapy, vaccines, and early diagnosis based on neuroimaging, CSF, and plasma biomarkers.
As of January 1, 2022, the yearly cost of the drug was slated to be roughly $28,200 USD annually, with the exact cost varying depending on the weight of the patient and their dosing level. The approval of this drug without a confirmed significant clinical impact has resulted in several debates. The approval is a departure from the FDA’s established process that requires two convincing studies before a drug is used.
Economics and cost
Aducanumab was recently approved by the Food and Drug Administration despite the lack of clinical effectiveness data. The inconsistencies can be linked with fewer numbers of patients in the ENGAGE trial receiving higher doses of aducanumab. Based on this finding, the ENGAGE trial protocol was amended to allow patients with APOE4 gene carriers to receive higher doses. Subgroup analysis after protocol amendment showed similar results as the EMERGE trail 46.
- It was not tested in people who had progressed to moderate dementia – a state in which the patients lose the ability to care for and feed themselves.
- In June 2021, aducanumab received its first approval in the USA for the treatment of Alzheimer’s disease.
- When assessments of progress in more than 3,000 subjects could be fully analyzed, benchmarks like their scores on the Mini-Mental State Exam (used to measure severity of thinking problems caused by Alzheimer’s) showed improvement compared to those who took a placebo.
- Relevant search terms such as aducanumab OR anti beta-amyloid therapy OR immunotherapy OR monoclonal antibody and Alzheimer’s disease OR dementia OR mild cognitive impairment were used.
Ensure that infusions are scheduled every four weeks, maintaining at least a 21-day gap between them.
However, many of the trials on anti-β-amyloid therapies have failed to demonstrate clinical impact or pose safety concerns. They state that even after considering the issues caused by the termination of these trials prematurely, having only one positive trial with the other trial being negative means that the evidence regarding the drug’s efficacy is not conclusive. Additionally, the authors indicate that, although plausible, the claims about lack of sufficient exposure to high-dose aducanumab and the role of variations in placebo group and low-dose group outcomes are also inconclusive. They state that the available biomarker data from both trials do not support a claim of clinically relevant cognitive benefits due to target engagement by aducanumab for Aβ PET and tau PET as neither target engagement was linked to cognition. The authors conclude that there is a need for a third phase III trial that is optimally designed and adequately powered to prove the clinical efficacy of aducanumab for MCI and mild AD.
Aducanumab became cost-effective when priced below $3000/y, whereas owing to its possibly greater efficacy (based on phase 2 trial data) and limited-duration dosing, donanemab was cost-effective when priced around $20 000/y. Aducanumab is an antibody infusion that recently received FDA approval as a drug that eases symptoms of Alzheimer’s disease, especially for people in the early stages. Sold under the brand name Aduhelm, aducanumab is from cloned immune cells (called “monoclonal antibodies”) that help fight dementia by targeting amyloid-beta.
In January 2024, drug-maker Biogen announced it would be discontinuing the development and commercialization of aducanumab/Aduhelm worldwide, as well as ending a related clinical study. Aducanumab (brand name Aduhelm) was an Alzheimer’s disease drug that received much global news coverage in 2021 and 2022. The drug was not commercially available in Canada, as drug-maker Biogen withdrew it from Health Canada review in June 2022. The swelling or bleeding that comes from ARIA can be monitored via brain scans for people taking Aducanumab. The drugmaker recommends MRI scans that detect ARIA before the 7th and 12th infusions, as the problems typically develop in the first 12 to 16 weeks of treatment and are asymptomatic (meaning a person can’t feel them happening). During trials, ARIA was detected in 41% of people taking Aducanumab, compared to 10% of those in the control group who did not take the drug.
Cost‐effectiveness of aducanumab to prevent Alzheimer’s disease progression at current list price
Last month, Medicare announced one of the largest increases ever in its “Part B” monthly premium for outpatient care. It said it would raise the premium nearly $22, from $148.50 currently to $170.10 starting in January. The drugmaker said Monday that it will cut the wholesale acquisition cost of the drug by about 50% next month. Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.