The U.S. Food and Drug Administration has accredited a supplemental Biologics License Application for a subcutaneous type of lecanemab, branded as LEQEMBI IQLIK, for the remedy of early Alzheimer’s illness, Eisai Co., Ltd. and Biogen Inc. introduced.
This approval introduces a once-weekly, at-home administration possibility through an autoinjector, providing a handy different to intravenous dosing from the beginning of remedy. The routine begins with a 500 mg initiation dose, delivered as two 250 mg injections. After 18 months of remedy, a upkeep dose of 360 mg weekly is on the market.
LEQEMBI is indicated for adults with delicate cognitive impairment or delicate dementia attributable to Alzheimer’s illness. Clinical knowledge from the Phase 3 Clarity AD long-term extension research demonstrated that subcutaneous administration achieves publicity equal to intravenous dosing, with comparable efficacy and security profiles.
Howard Fillit, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer’s Drug Discovery Foundation, highlighted the importance of this growth, noting the elevated flexibility and selection it gives to sufferers and their care companions.
The subcutaneous possibility goals to scale back the burden of clinic visits, reliance on healthcare assets, and remedy preparation time, whereas preserving infusion capability for many who favor intravenous remedy. An autoinjector acceptability examine reported excessive satisfaction and confidence ranges amongst sufferers and care companions utilizing the machine at house.