0
0
The U.S. Food and Drug Administration (FDA) has granted approval for a new monthly maintenance dosing regimen for Leqembi, an Alzheimer’s drug developed by Japan’s Eisai and its partner Biogen. This approval marks a significant step forward for the treatment, as it addresses a challenge that has slowed its growth—its cumbersome administration process.
Leqembi, which received standard U.S. approval in 2023, showed promising results in clinical trials by slowing cognitive decline in patients with Alzheimer’s disease. However, its growth has been slower than expected, partly due to the logistical burden of its current bi-weekly intravenous infusion process. Additionally, patients must undergo regular MRIs and screenings as part of the treatment.
With the new approval, patients who have received the drug through bi-weekly infusions for 18 months will now have the option to switch to a monthly dose. Alternatively, they can continue with the bi-weekly regimen if they prefer.
Leqembi works by targeting and clearing amyloid beta, a protein that forms sticky plaques in the brain, widely believed to be a key contributor to the progression of Alzheimer’s. The drug is administered at an infusion center, and the entire process typically takes about an hour.
The approval for monthly maintenance dosing follows simulations of trial data, which suggest that this new dosing schedule would maintain the therapeutic benefits of the drug while improving convenience for patients. The companies believe that this change will make it easier for more people to access and adhere to the treatment.
This move comes in the wake of a competing Alzheimer’s drug, Eli Lilly’s Kisunla, which was approved in July and offers a once-a-month infusion. However, unlike Leqembi, Kisunla’s treatment stops when brain scans no longer show amyloid plaques.
Both Leqembi and Kisunla carry safety warnings regarding the potential for brain swelling and bleeds, making regular monitoring through brain scans a crucial part of treatment.
Disclaimer:
This article is for informational purposes only and does not constitute medical advice. The FDA approval of monthly maintenance dosing for Leqembi is subject to ongoing medical evaluation, and patients should consult their healthcare providers to determine the best course of treatment for their individual conditions.
