FDA Approves Extended Dosing Regimen for Alzheimer’s Treatment
In a significant advancement for Alzheimer’s treatment, the U.S. Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once-every-four-weeks intravenous (IV) maintenance dosing of LEQEMBI (lecanemab-irmb).
This approval introduces a more flexible treatment schedule, potentially easing the burden on patients with early Alzheimer’s disease (AD) and their caregivers.
LEQEMBI is specifically designed for individuals experiencing mild cognitive impairment (MCI) or mild dementia due to AD. The treatment protocol initially requires biweekly infusions for 18 months before transitioning to a monthly regimen. This newly approved four-week dosing schedule could simplify long-term care while maintaining clinical benefits.
The FDA’s decision is based on robust data from phase 2 and Clarity AD studies, which demonstrated that the less frequent dosing preserves both clinical and biomarker efficacy.
LEQEMBI operates by uniquely targeting both amyloid plaque and protofibrils – two harmful agents in the progression of AD. While clearing plaque is essential, protofibrils continue to harm neurons even after plaque removal, making ongoing treatment critical.
One of the most pressing challenges in Alzheimer’s treatment is disease progression. Discontinuing therapy can result in the reaccumulation of amyloid deposits and a return to the placebo rate of cognitive decline.
The option of once-a-month maintenance dosing may encourage patients to continue treatment, potentially slowing disease advancement and extending cognitive function.
The Clarity AD study further reinforced LEQEMBI’s clinical significance, showing a meaningful reduction in cognitive decline compared to placebo over three years. These findings support the treatment’s role in early-stage AD management, offering hope for prolonged quality of life.
LEQEMBI has gained regulatory approval in multiple countries and recently received a positive opinion from the European Medicines Agency. Eisai spearheads global development and regulatory submissions, co-commercialising with Biogen to expand treatment access.
To conclude, the FDA’s approval of an extended dosing regimen for LEQEMBI marks an important step in Alzheimer’s care, balancing treatment efficacy with improved patient convenience.
With continued advancements in AD research, such developments signal progress in the fight against this relentless disease, offering new possibilities for those diagnosed in its early stages.
News Credits: FDA approves new Alzheimer’s treatment regimen
Things you may also like:
- Europe’s First Biomarker Trial to Prevent Crohn’s Disease
- Cebranopadol Shows Promising Results in Treating Acute Pain
- Bramble Foods Group Acquires Whitakers Chocolates