The U.S. Meals and Drug Administration has accredited Leqembi Iqlik, a subcutaneous model of lecanemab, for weekly upkeep after the 18-month intravenous (IV) part.
Leqembi Iqlik is a subcutaneous autoinjector that delivers therapy in about 15 seconds for U.S. sufferers with Alzheimer’s illness on the gentle cognitive impairment or gentle dementia stage. After finishing 18 months of IV dosing, sufferers might both proceed month-to-month IV infusions or swap to the brand new weekly 360-mg subcutaneous injection. This development is supposed to permit sooner, less complicated dosing and helps future mixture remedy approaches.
“This shift to subcutaneous maintenance dosing is a crucial step towards making Leqembi more accessible for patients, similar to how diabetes and GLP-1 medications are delivered, and represents the first step towards the day when patients can bypass infusions altogether,” Howard Fillit, M.D., cofounder and chief science officer on the Alzheimer’s Drug Discovery Basis, stated in a press release.
He added, “This milestone lessens the burden on patients and caregivers by reducing the logistical challenges of receiving Alzheimer’s treatment, while also bringing us closer to the day when patients can more easily receive a combination of drugs, potentially administered from home.”
FDA approval was supported by part 3 Readability AD extension trial information, displaying that switching to the weekly Leqembi Iqlik autoinjector after 18 months of IV dosing maintains medical and biomarker advantages akin to ongoing IV therapy in early Alzheimer’s illness.
Subcutaneous Leqembi confirmed a security profile just like IV dosing, however with a serious benefit: Systemic reactions occurred in lower than 1% of sufferers versus about 26% with IV infusions. Amyloid-related imaging abnormality charges with the weekly 360-mg subcutaneous dose had been akin to these seen with continued IV dosing after 18 months and had been just like background charges seen in untreated sufferers.
Approval of Leqembi Iqlik was granted to Eisai and Biogen.
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FDA approves subcutaneous Leqembi for therapy of early Alzheimer’s illness (2025, September 2)
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