Quick access to main page (top) Direct access to main contents Quick access to main page (bottom)

Eli Lilly’s Alzheimer’s Treatment Under Review by FDA Advisory Committee

Daniel Kim Views  

The U.S. Food and Drug Administration (FDA) advisory committee will discuss Eli Lilly’s Donanemab for Alzheimer’s treatment on June 10th.

Eli Lilly’s Donanemab is developed to eliminate the toxic Alzheimer ‘s-related protein beta-amyloid accumulated in the brain and is administered once a month via injection.

Donanemab was denied accelerated approval by the FDA in January last year and delayed when they received a notice from the FDA on March 8th of the same year to form an advisory committee to discuss Donanemab.

The independent advisory committee discussed Donanemab and LEQEMBI from Eisai and partner Biogen. However, while Donanemab’s approval has been delayed twice in the U.S., LEQEMBI, a drug similar to Donanemab, received FDA approval last year.

Clinical trial results showed that Donanemab treatment could delay the progression of memory and cognitive decline caused by Alzheimer’s disease by 22% to 29%, which is considered comparable to LEQEMBI’s 27% detain effect.

Furthermore, Donanemab showed that it could delay the progression of the disease in patients with mild to moderate levels of the second Alzheimer ‘s-related protein, Tau, by up to 35.1%.

However, experts predict that the approval process will not go smoothly due to the risk of brain edema and bleeding side effects associated with Donanemab.

Daniel Kim
content@viewusglobal.com

Comments0

300

Comments0

[LATEST] Latest Stories

  • Pfizer Ends Obesity Drug Trial After Liver Risk Emerges
  • Not Just Old Age: The Pneumonia That Affected Pope Francis’ Final Years
  • China Just Cranked U.S. Tariffs to 84% — And That’s Not the End of It
  • BMW's Next-Gen EV: The Bold New i3 Touring Concept Revealed
  • LEGO Technic Ferrari SF-24 F1 Car: A 1,361-Piece Tribute to Ferrari’s 2024 F1 Season
  • Hyundai’s Ioniq 6 Just Took the Top Spot in J.D. Power’s EV Ownership Study

You May Also Like

  • 1
    Too Much Sitting May Raise Risk of Alzheimer’s, Even If You Exercise, Study Finds

    LIFESTYLE 

  • 2
    Got a Family History of Rare Dementia? This Gene Might Protect You

    LIFESTYLE 

  • 3
    Experts Say Tea, Apples, and Cocoa Might Be the Secret to Lower BP

    LIFESTYLE 

  • 4
    Living Near a Golf Course? Your Risk for Parkinson’s Might Be Higher

    LIFESTYLE 

  • 5
    Prunes: The Underrated Superfruit Your Cardiologist Might Approve Of

    LIFESTYLE 

Popular Now

  • 1
    3 Daily Habits That Might Be Aging Your Brain Faster Than You Think

    LIFESTYLE&nbsp

  • 2
    The One-Spoon Habit That’s Taking Over Healthy Mornings

    LIFESTYLE&nbsp

  • 3
    Tired of Painful Periods? Your Pantry Might Hold the Cure

    LIFESTYLE&nbsp

  • 4
    Still Tired After 8 Hours of Sleep? This Could Be Why

    LIFESTYLE&nbsp

  • 5
    Scientists Link Let-7 Gene to Lung Healing—and Possibly a Cure for Fibrosis

    LIFESTYLE&nbsp

Must-Reads

  • 1
    Too Much Sitting May Raise Risk of Alzheimer’s, Even If You Exercise, Study Finds

    LIFESTYLE 

  • 2
    Got a Family History of Rare Dementia? This Gene Might Protect You

    LIFESTYLE 

  • 3
    Experts Say Tea, Apples, and Cocoa Might Be the Secret to Lower BP

    LIFESTYLE 

  • 4
    Living Near a Golf Course? Your Risk for Parkinson’s Might Be Higher

    LIFESTYLE 

  • 5
    Prunes: The Underrated Superfruit Your Cardiologist Might Approve Of

    LIFESTYLE 

Popular Now

  • 1
    3 Daily Habits That Might Be Aging Your Brain Faster Than You Think

    LIFESTYLE 

  • 2
    The One-Spoon Habit That’s Taking Over Healthy Mornings

    LIFESTYLE 

  • 3
    Tired of Painful Periods? Your Pantry Might Hold the Cure

    LIFESTYLE 

  • 4
    Still Tired After 8 Hours of Sleep? This Could Be Why

    LIFESTYLE 

  • 5
    Scientists Link Let-7 Gene to Lung Healing—and Possibly a Cure for Fibrosis

    LIFESTYLE