FDA approves first at-home injector, while recommending patients undergo additional MRI before third infusion
Lecanemab autoinjector
The FDA has approved a new autoinjector formulation for lecanemab, an antiamyloid therapy indicated for patients with early-stage Alzheimer disease and mild cognitive impairment from AD. The subcutaneous autoinjector becomes the first-ever at-home, self-administered option for ongoing AD treatment, improving convenience and access for patients in the United States.
The new autoinjector, approved based on data from the phase 3 Clarity AD trial (NCT03887455), provides quicker administration – lasting about 15 seconds total. In clinical trial settings, it demonstrated comparable exposure, improved tolerability, enhanced amyloid clearance, and better user-friendliness in patient, caregiver, and healthcare surveys. In addition, there is a belief that this new autoinjector will have significant societal cost savings, lowering treatment and administration expenses.
Additional MRI scanning
Meanwhile, patients receiving Leqembi are now recommended to undergo an MRI before receiving their third infusion of the drug in order to identify those with amyloid-related imaging abnormalities with oedema (ARIA-E).
In Leqembi’s prior FDA prescribing information, MRI imaging was recommended before patients’ 5th, 7th and 14th infusions. After analysis of the ARIA-E safety issue, the FDA has determined that earlier monitoring could help alleviate the risk. The recommendations for the subsequent scans are unchanged.
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Specifically, the FDA identified six deaths early in treatment, prompting a deeper look into serious ARIA-E outcomes prior to patients’ 5th infusion of Leqembi.
The FDA will update its prescribing information to note the recommended MRI between the 2nd and 3rd Leqembi infusions. ARIA-E is characterised by brain swelling or fluid build-up and is often asymptomatic, although serious and life-threatening events can occur.
The prescribing information for Eli Lilly’s rival Alzheimer’s disease treatment Kisunla calls for MRIs before patients’ 2nd, 3rd, 4th and 7th infusions.
