The US Food and Drug Administration (FDA) has approved a once-weekly autoinjector version of Eisai’s Alzheimer’s drug Leqembi (lecanemab), as the company seeks to grow the medicine’s uptake amid reimbursement struggles.
The new injection, which will be known under the brand name Leqembi IQLIK, will be available to early Alzheimer’s patients who are moving onto maintenance dosing, having already received the drug intravenously (IV) every two weeks for 18 months. Leqembi IQLIK will be launched in the US in October 2025.
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The FDA approved the 360mg autoinjector as another option for maintenance dosing of the beta-amyloid blocker, with patients currently remaining on intravenous infusions dropping down to a once-monthly dose of 10mg/kg. The once-monthly IV dosing regimen was approved by the FDA in January 2025.
Overseeing regulatory submissions for Leqembi, Eisai was initially supposed to file the biologics licence application (BLA) for the autoinjector in March 2024, but the FDA requested more immunogenicity data, leading to a delay in filing. The company eventually initiated the rolling submission in May 2024.
In a joint statement, Eisai and commercial partner Biogen said the autoinjector’s approval allows patients to receive the therapy at home while on a maintenance dose, negating the need to visit an infusion centre. The pen’s availability for a subset of patients also increases infusion capacity for new patients to begin treatment.
Leqembi is now the only approved amyloid-based therapy for Alzheimer’s that can be administered at home. Equipped with just a 15-second injection time, it marks a steep reduction from the one hour it usually takes for an infusion.
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By GlobalDataThe FDA based its decision on results from the Phase III CLARITY AD (NCT03887455) study that demonstrated no efficacy difference between patients switching onto the autoinjector pen after 18 months of the initiation dose.
Leqembi was the spearhead in a new generation of Alzheimer’s drugs that slow disease progression. Eisai and Biogen enjoyed market dominance upon Leqembi’s approval in 2023, though this was ended when Eli Lilly received FDA approval for Kisunla (donanemab) in 2024. Both drugs are approved in the same Alzheimer’s indication, though they have different mechanisms of action.
Leqembi targets small chains of linked-up beta-amyloid proteins called protofibrils, which in turn prevent amyloid buildup. Meanwhile, Kisunla only targets the beta-amyloid plaques.
However, both sets of companies have struggled for uptake of their medications amid their high prices. Reimbursement regulators across many countries have shunned the medication, saying the costs associated with administering the drug do not outweigh its benefits.
Eisai has previously stated particularly slow uptake in the US, hampered by infusion logistics and diagnosis constraints.
Nevertheless, Eisai is hoping Leqembi will generate Y250bn to Y280bn ($1.7bn to $1.9bn) in sales in its 2027 fiscal year.
Analysis by GlobalData’s Pharma Intelligence Center forecasts sales of $1.5bn in 2027 and $2.2bn in 2028.
GlobalData is the parent company of Pharmaceutical Technology.
