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    Home > Active Ingredient News > Study of Nervous System > The FDA approved the first new drug for Alzheimer's disease in 18 years. What does this mean?

    The FDA approved the first new drug for Alzheimer's disease in 18 years. What does this mean?

    • Last Update: 2021-06-17
    • Source: Internet
    • Author: User
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    ▎Editor of WuXi AppTec's content team On June 7, local time, the US FDA announced that it has accelerated the approval of the listing of Aduhelm (aducanumab), a monoclonal antibody therapy for Alzheimer's disease (AD) developed by Biogen
    .

    This is the first new therapy approved by the FDA for the treatment of AD since 2003, and it is also the first new therapy approved by the FDA to target the underlying disease mechanism of AD
    .

    Since Bojian and Eisai jointly announced two years ago that they planned to submit a biologics license application (BLA) for aducanumab to the FDA, the review process of this innovative treatment has been subject to drug developers, doctors, patients, etc.
    Multi-party attention
    .

    Today's accelerated approval has also triggered widespread heated discussions in the industry
    .

    What does the accelerated approval of the FDA mean? What new therapies in this field are worth looking forward to in the future? Confirmation tests are also required.
    This FDA approval is based on the accelerated approval channel
    .

    This channel is used to approve innovative therapies for the treatment of serious or life-threatening diseases
    .

    A statement issued by the FDA pointed out that Aduhelm’s accelerated approval is based on its impact on the surrogate endpoint, which consistently reduces the levels of amyloid plaque in the brains of patients in phase 3 clinical trials
    .

    ▲ Bojian’s Aduhelm reduced the level of amyloid plaques in patients’ brains in a dose- and time-dependent manner in two phase 3 clinical trials (Image source: Bojian’s official website) Amyloid plaques are a hallmark of AD patients’ brains One of the characteristics, there are also a variety of treatments under investigation to reduce the deposition of amyloid plaques or the production of amyloid beta that leads to the deposition.

    .

    A statement issued by the FDA stated that the reduction in amyloid plaque deposition is "reasonably likely to predict" the clinical benefit to patients
    .

    The FDA also requires Bojian to conduct confirmatory clinical trials after obtaining accelerated approval to prove the clinical benefit of Aduhelm on the cognitive abilities of AD patients
    .

    If the confirmatory test fails to prove the expected clinical benefit, the FDA may withdraw the accelerated approval of the drug
    .

    What other treatments have similar mechanisms? In the field of AD research and development, the "amyloid hypothesis" can be said to be one of the most studied AD pathogenesis theories, but it is also a very controversial hypothesis
    .

    The "amyloid hypothesis" believes that AD disease is caused by the excessive accumulation of beta amyloid, which triggers a series of downstream reactions, which ultimately leads to the damage and death of nerve cells in the brain
    .

    However, a number of previously researched therapies targeting amyloid have failed to show significant efficacy in phase 3 clinical trials, making people doubt this hypothesis
    .

    In two phase 3 clinical trials conducted by Bojian, although Aduhelm consistently caused a decrease in the level of amyloid plaques in the patients' brains, the relief of indicators of cognitive decline in patients was not consistent
    .

    Image source: 123RF Bojian’s further analysis of the test data pointed out that allowing patients to continue to receive high-dose Aduhelm treatment can lead to a greater reduction in the level of amyloid in the brain of the patients, and the rate of cognitive decline in these patients A more significant delay
    .

    These results may mean that amyloid-targeted therapy needs to reduce the amyloid in the brain to a low enough level to be able to observe the effect of delaying cognitive decline
    .

    Previously, Lilly's development of AD antibody therapy donanemab's Phase 2 clinical trial results also revealed the relationship between a substantial decline in amyloid levels and a slowdown in cognitive decline
    .

    Donanemab can quickly remove amyloid deposits in the brain by binding to specific beta amyloid subtypes in amyloid plaques
    .

    Positron scanning (PET) imaging showed that after 6 months of treatment, 40% of patients had a negative PET test, meaning that the level of amyloid deposits in their brains was not significantly different from that of healthy people
    .

    After 18 months of treatment, 61% of patients reached a level of negative PET testing
    .

    ▲Donanemab significantly cleared the amyloid deposits in the brains of patients (picture source: Reference [8]) These patients, after 76 weeks of treatment, the combined index iADRS, which assesses the patients’ cognitive ability and ability of daily living, is comparable to the placebo group Compared with, the reduction rate is reduced by 32% (p=0.
    04)
    .

    Roche has also launched two phase 3 clinical trials to test the effect of high-dose amyloid antibody gantenerumab in early AD patients
    .

    The company has also developed a "brain shuttle" technology that can help gantenerumab cross the blood-brain barrier, thereby more effectively removing amyloid deposits in the brain
    .

    The causality between the level of amyloid plaques in AD patients and the cognitive decline of patients is the key to whether the "amyloid hypothesis" can lead to effective therapy
    .

    A number of subsequent clinical studies are expected to further clarify the relationship between the two
    .

    Beyond amyloid, a number of new mechanism therapies are under development.
    "Aducanumab is only the first of many AD drugs that are expected to benefit patients in the next 5-10 years.

    .

    "The Alzheimer’s Disease Drug Discovery Foundation (ADDF) founding executive director and chief scientific officer, Dr.
    Howard Fillit, said, "AD’s rich R&D pipeline, and the emergence of more biomarkers and other important research tools mean that it is currently The clinical trials being conducted are more rigorous and more promising
    .

    "Aduhelm's Phase 3 clinical trial is one of the first clinical trials that use PET scans to ensure that suitable patients are enrolled and use it to detect the effects of drugs on the brain
    .

    The Phase 2 clinical trials conducted by Eli Lilly use PET scans to test starch.
    In addition to the deposition of amyloid-like protein, similar methods have also been used to detect the level of tau protein in the patient’s brain
    .

    In addition to advances in clinical trial design and patient evaluation, the development of drugs for AD is not limited to targeting amyloid
    .

    For 2020 An analysis of the AD drug research and development pipeline pointed out that in the AD clinical trials published on the ClinicalTrials.
    gov website in 2020, only 35% of the 29 investigational therapies in phase 3 clinical trials target amyloid, and other therapies under investigation the mechanism of action includes a plurality of new mechanisms of synaptic plasticity and neuroprotection, inflammation / infection / immunity
    .

    ▲ in three clinical trials of AD have several different mechanisms of action (source investigational therapy: references [5]) In the phase 2 clinical trials, the trend of diversification of the mechanism of action is more obvious, and only 20% of the 55 treatments under investigation that change the course of the disease target amyloid
    .

    Related reading: Beyond amyloid and tau , The clinical development of Alzheimer's disease has entered an era of diversification.
    "This FDA approval has opened up a new era of AD treatment and research
    .

    "Alzheimer's Association (Alzheimer's Association) CEO Dr.
    Maria C.
    Carrillo said: "History tells us that the approval of the first new type of drug will inspire the entire field, stimulate investment in innovative therapies and encourage greater innovation.

    .

    We look forward to today’s approval, whether for this new drug or for the development of better treatments for patients with Alzheimer’s disease, it is just the beginning
    .

    "Reference: [1] FDA's Decision to Approve New Treatment for Alzheimer's Disease.
    Retrieved June 7, 2021, from https:// new-treatment-alzheimers-disease[2] Alzheimer's Association Welcomes FDA Approval of Aducanumab.
    Retrieved June 7, 2021, from https:// -ad[3] Alzheimer's Drug Discovery Foundation Statement on FDA Approval of Aducanumab.
    Retrieved June 7, 2021, from https:// -approval-of-aducanumab-301306963.
    html[4] 2021 ALZHEIMER'S DISEASE FACTS AND FIGURES.
    Retrieved June 7, 2021, from https:// [5] Cummings et al.
    , (2020).
    Alzheimer's disease drug development pipeline: 2020.
    Translational Research & Clinical Interventions.
    DOI: 10.
    1002/trc2.
    12050[6] FDA Grants Accelerated Approval for Alzheimer's Drug.
    Retrieved June 7, 2021, from https:// -approval-for-alzheimers-drug-301306966.
    html[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer's disease treatment to address a defining pathology of the disease.
    Retrieved June 7, 2021, from https:// treatment-to-address-a-defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Note: This article aims to introduce Medical and health research progress, not a treatment plan recommendation1002/trc2.
    12050[6] FDA Grants Accelerated Approval for Alzheimer's Drug.
    Retrieved June 7, 2021, from https:// -301306966.
    html[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer's disease treatment to address a defining pathology of the disease.
    Retrieved June 7, 2021, from https:// release/2021/06/07/2243019/0/en/FDA-grants-accelerated-approval-for-ADUHELM-as-the-first-and-only-Alzheimer-s-disease-treatment-to-address-a- defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Note: This article aims to introduce medical and health research progress, not a treatment plan recommend1002/trc2.
    12050[6] FDA Grants Accelerated Approval for Alzheimer's Drug.
    Retrieved June 7, 2021, from https:// -301306966.
    html[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer's disease treatment to address a defining pathology of the disease.
    Retrieved June 7, 2021, from https:// release/2021/06/07/2243019/0/en/FDA-grants-accelerated-approval-for-ADUHELM-as-the-first-and-only-Alzheimer-s-disease-treatment-to-address-a- defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Note: This article aims to introduce medical and health research progress, not a treatment plan recommendcom/news-releases/fda-grants-accelerated-approval-for-alzheimers-drug-301306966.
    html[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer's disease treatment to address a defining pathology of the disease.
    Retrieved June 7, 2021, from https:// -and-only-Alzheimer-s-disease-treatment-to-address-a-defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendationcom/news-releases/fda-grants-accelerated-approval-for-alzheimers-drug-301306966.
    html[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer's disease treatment to address a defining pathology of the disease.
    Retrieved June 7, 2021, from https:// -and-only-Alzheimer-s-disease-treatment-to-address-a-defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation// disease-treatment-to-address-a-defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Introducing the progress of medical and health research, not a treatment plan recommendation// disease-treatment-to-address-a-defining-pathology-of-the-disease.
    html[8] Mintun et al.
    , (2021).
    Donanemab in Early Alzheimer's Disease.
    NEJM, DOI: 10.
    1056/NEJMoa2100708 Introducing the progress of medical and health research, not a treatment plan recommendation
    .

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