Donanemab

FDA Delays Approval of Donanemab for the Treatment of Early-Stage Alzheimer’s

Retrieved on: 
Friday, March 8, 2024

About UsAgainstAlzheimer’sUsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and equal access to treatments regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.

Key Points: 
  • WASHINGTON, March 08, 2024 (GLOBE NEWSWIRE) -- The maker of donanemab, Eli Lilly, announced today that the Food and Drug Administration (FDA) will convene an advisory committee to consider the drug’s safety and efficacy, further delaying approval of the promising drug.
  • UsAgainstAlzheimer’s issued the following statement in response:
    “As patients, we’re obviously disappointed by any delay.
  • We know that about 2,000 people per day progress to more advanced stages of the disease, so we urge the FDA to schedule this advisory committee as soon as possible to discuss these important questions.”

Alzheimer's Drug Discovery Foundation (ADDF) Statement on FDA Decision to Convene Advisory Committee for Donanemab

Retrieved on: 
Friday, March 8, 2024

NEW YORK , March 8, 2024 /PRNewswire/ -- Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final decision on whether to grant the drug approval. The advisory committee is scheduled to take place later this year.

Key Points: 
  • The FDA plans to hold an advisory committee to glean more information on the TRAILBLAZER-ALZ 2 trial data and safety profile.
  • The advisory committee is scheduled to take place later this year.
  • "Today's FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients," says Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF).
  • "The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi."

Neurophet introduces AI-powered brain imaging analysis technology at AD/PD 2024

Retrieved on: 
Monday, March 4, 2024

SEOUL, South Korea, March 4, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its participation in the international conference on Alzheimer's and Parkinson's diseases and related neurological disorders (AD/PD 2024).

Key Points: 
  • At this conference, Neurophet will introduce Alzheimer's disease treatment related technologies planned to be commercialized such as analysis of the side effect and amyloid-positive prediction.
  • Neurophet AQUA analyzes brain atrophy and white matter hyperintensities (WMH) found in brain MRI of most Alzheimer's disease patients.
  • Neurophet SCALE PET provides quantitative regional amyloid beta deposition, known as the causative agent of Alzheimer's disease, using PET images.
  • Neurophet plans to launch total solution for Alzheimer's disease treatment including ARIA analysis, since Neurophet has the technology to analyze ARIA.

Breakthrough in Treating Alzheimer's Using Targeted Drug Delivery Reported in New England Journal of Medicine

Retrieved on: 
Wednesday, January 3, 2024

Anti-amyloid-beta (Aβ) monoclonal antibody therapies, such as aduncaumab, lecanemab, and donanemab, can reduce amyloid-beta plaques and slow the progression of Alzheimer’s.

Key Points: 
  • Anti-amyloid-beta (Aβ) monoclonal antibody therapies, such as aduncaumab, lecanemab, and donanemab, can reduce amyloid-beta plaques and slow the progression of Alzheimer’s.
  • More than 98 percent of drugs do not readily cross the BBB, thus requiring systemic treatments with higher doses and more frequent therapies.
  • The FUS MRI-guided treatment helmet with more than 1,000 ultrasound transducers were directed to specific brain regions with high amyloid-beta plaques.
  • “We are hopeful that the work we are doing may lead to improvements in outcome for many other patients and their families coping with Alzheimer’s.”

Eisai to Present New Data from LEQEMBI (Lecanemab-Irmb) Phase 3 Clarity Ad Study and Other Alzheimer's Disease Pipeline Research at The Clinical Trials on Alzheimer's Disease (CTAD) Conference

Retrieved on: 
Monday, October 16, 2023

The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.

Key Points: 
  • The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.
  • At the conference, Eisai will present data and research in five oral and ten poster presentations.
  • "We look forward to sharing the new LEQEMBI low-tau subgroup data and subcutaneous data at CTAD 2023."
  • The full list of presentations about Eisai assets and research, click the link: www.eisai.com/news/2023/news202365.html

Alzheimer's disease is partly genetic − studying the genes that delay decline in some may lead to treatments for all

Retrieved on: 
Saturday, September 16, 2023

Others are risk genes that affect the body in a way that increases the chance someone will develop the disease.

Key Points: 
  • Others are risk genes that affect the body in a way that increases the chance someone will develop the disease.
  • In Alzheimer’s disease, genetic mutations in any of three specific genes can cause the disease, and other risk genes either increase or decrease the risk of developing Alzheimer’s.
  • Some genetic mutations or variants interact with other genetic alterations that lead to Alzheimer’s disease.

The amyloid hypothesis

    • In the early 1990s, scientists proposed the amyloid hypothesis to explain how Alzheimer’s disease develops.
    • These findings added strength to the amyloid hypothesis explanation of the disease.
    • However, uncertainty and opposition to the amyloid hypothesis have developed over the past several decades.
    • But until a clinical trial based on the amyloid hypothesis could show definitive results, uncertainty would remain.

Genetic discoveries with treatment implications

    • However, a relatively small number of families have one of the three known genetic mutations that cause the disease to be passed down.
    • In familial Alzheimer’s, 50% of each generation will inherit the mutated gene and develop the disease much earlier, usually from their 30s to early 50s.
    • These mutated genes were found in a very large family in Colombia whose members tended to develop Alzheimer’s symptoms by their 40s.
    • A genetic analysis showed that she had an additional mutation in a variant of the gene that codes for a protein called apolipoprotein E, or ApoE.

Starts and stops

    • Although there is still discussion of how much slowing of decline is clinically significant, these successes provide support for the amyloid hypothesis.
    • They also suggest that other strategies will be needed for optimal treatment.
    • The U.S. Food and Drug Administration’s 2021 approval of the first antibody treatment for Alzheimer’s, aducanumab, sold under the brand name Aduhelm, was controversial.

APRINOIA Therapeutics Announces Strategic Investment From The Alzheimer’s Drug Discovery Foundation (ADDF)

Retrieved on: 
Monday, September 11, 2023

Investment Supports APRINOIA’s Effort to Bring Precision Medicine to Neuroscience, Advancing APRINOIA’s Diagnostic and Therapeutic Pipelines

Key Points: 
  • Investment Supports APRINOIA’s Effort to Bring Precision Medicine to Neuroscience, Advancing APRINOIA’s Diagnostic and Therapeutic Pipelines
    CAMBRIDGE, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- APRINOIA Therapeutics (“APRINOIA” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics and precision diagnostics for the treatment of neurodegenerative diseases, headquartered in Cambridge, MA, is pleased to announce the strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) of approximately $4.4M.
  • Accumulation of misfolded tau aggregates is a pathological hallmark of AD and several neurodegenerative diseases collectively known as tauopathies, including PSP.
  • There are very few drug development efforts in neuroscience that are pursuing this potentially transformative approach.
  • With the ADDF’s investment, APRINOIA plans to produce clinical-stage protein degraders capable of penetrating the blood-brain-barrier (BBB), to enter brain cells and clear toxic aggregated forms of tau.

New Alzheimer's drugs don't deserve the hype – here's why

Retrieved on: 
Thursday, August 31, 2023

Naturally, this makes me desperate for good news on treatment options for Alzheimer’s disease – the main cause of dementia.

Key Points: 
  • Naturally, this makes me desperate for good news on treatment options for Alzheimer’s disease – the main cause of dementia.
  • Enter three drugs (aducanumab (trade name Aduhelm), lecanemab (Leqembi) and donanemab) that remove amyloid, the protein thought to cause Alzheimer’s disease.
  • Unlike their many predecessors, that also successfully removed amyloid from the brain, these drugs were the first to slow cognitive decline.
  • This breakthrough was hailed as “the beginning of the end for Alzheimer’s disease”, but how useful are these drugs going to be?
  • If the drug eligibility is restricted to match the trial eligibility, then very few people will be eligible.
  • If eligibility is broader, then already small effects are likely to be even smaller and side-effects more pronounced.

Profound shortcomings

    • Sadly, I don’t think these drugs can make a big difference for people currently, or soon to be, living with Alzheimer’s disease.
    • Also, the shortcomings are so profound, despite decades of expensive trials and patient sacrifice, I think it’s time to take the amyloid blinkers off and prioritise exploring other, neglected, options for treating dementia.
    • This isn’t the beginning of the end of Alzheimer’s, but perhaps it should be the end of the anti-amyloid drug pathway.

Global Alzheimer's Disease Market 2023-2032: LEQEMBI and Donanemab Reshape Treatment Landscape - ResearchAndMarkets.com

Retrieved on: 
Monday, August 28, 2023

Alzheimer's disease, a progressive neurodegenerative disorder, is on the rise due to the aging population and increased disease awareness.

Key Points: 
  • Alzheimer's disease, a progressive neurodegenerative disorder, is on the rise due to the aging population and increased disease awareness.
  • While the current treatment focuses on managing symptoms and slowing disease progression, recent breakthroughs in disease-modifying therapies are changing the landscape.
  • This report delves into key highlights, emerging therapies, market trends, and the epidemiology of Alzheimer's disease in the 7MM (United States, EU4, UK, and Japan).
  • The Alzheimer's disease landscape is witnessing transformative changes, driven by breakthrough therapies like LEQEMBI and donanemab.

Alzheimer’s Prevention Treatment Study Now Available for Seniors in Lake Charles

Retrieved on: 
Monday, August 14, 2023

As a result of this blood test, potentially at-risk participants can check for early pre-symptomatic signs of Alzheimer’s.

Key Points: 
  • As a result of this blood test, potentially at-risk participants can check for early pre-symptomatic signs of Alzheimer’s.
  • “Alzheimer’s is a devastating form of dementia that afflicts over 6 million Americans,” said Dr. Jason Morris, MD, the Care Access Principal Investigator for this study in Lake Charles.
  • “Detecting early preclinical Alzheimer’s, which can start 10 to 20 years before you have symptoms, with a simple blood test is an important opportunity for seniors here in our Lake Charles community.
  • Care Access opened its Lake Charles location in 2020, in collaboration with local community leaders and healthcare providers seeking to make clinical research more accessible to the greater Lake Charles community.