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news.The US Food and Drug Administration (FDA) has granted approval for Eisai and Biogen’s biologics licence application (BLA) for Leqembi Iqlik, a once-weekly subcutaneous injection maintenance dosing to treat early Alzheimer's disease (AD).
The safety of the autoinjector was evaluated in more than 600 patients as part of the Clarity AD trial. Credit: Sam Moghadam on Unsplash.
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This new dosing option enables patients with mild cognitive impairment or mild dementia to receive treatment at home, following an initial intravenous (IV) administration.
Leqembi Iqlik, administered through a subcutaneous autoinjector, contains 360mg/1.8ml (200mg/ml) and is delivered in roughly 15 seconds.
After 18 months of Leqembi IV treatment at a dosage of 10mg/kg every two weeks, patients have the option to either continue with IV infusions once every four weeks or switch to the new weekly subcutaneous injection.
The approval is based on subcutaneous sub-studies from the Phase III Clarity AD open-label extension in early AD.
These studies assessed various subcutaneous doses, revealing that switching to weekly Leqembi Iqlik after 18 months preserves clinical and biomarker benefits comparable to ongoing IV dosing.
The safety of the autoinjector was evaluated in more than 600 patients as part of the Clarity AD trial.
The safety profile for all subcutaneous doses was comparable to that of IV maintenance, with fewer systemic reactions occurring in less than 1% of patients, compared to nearly 26% with infusions.
Around 11% reported mild-to-moderate local reactions that did not disrupt dosing, while less than 1% reported mild systemic symptoms.
The incidence of amyloid-related imaging abnormalities (ARIA) with the weekly 360mg subcutaneous maintenance dose was akin to the rates observed in patients who continued with IV dosing after 18 months and was comparable to baseline rates in untreated individuals.
