FDA Approves Leqembi Iqlik Autoinjector for Early Alzheimer’s Treatment

The FDA has approved Leqembi Iqlik, an under-the-skin autoinjector, for maintenance dosing in early Alzheimer's disease. The approval applies to patients who first received the intravenous version for at least 1.5 years. The Leqembi Iqlik autoinjector has the potential to reduce the time and healthcare resources associated with intravenous dosing, taking about 15 seconds to administer. Eisai has started a rolling application to approve Leqembi Iqlik for initiation dosing, which has been granted fast track status.

The U.S. Food and Drug Administration (FDA) has approved Leqembi Iqlik, an under-the-skin autoinjector, for maintenance dosing in early Alzheimer's disease. The approval applies to patients who first received the intravenous version for at least 1.5 years. The Leqembi Iqlik autoinjector has the potential to reduce the time and healthcare resources associated with intravenous dosing, taking about 15 seconds to administer. Eisai has started a rolling application to approve Leqembi Iqlik for initiation dosing, which has been granted fast track status [1].

Leqembi, developed by Eisai and Biogen, is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. The drug targets both amyloid plaque and protofibrils, which can impact tau downstream. The approval of the autoinjector expands treatment options for patients, offering a choice between intravenous (IV) and subcutaneous (SC) administration. This can streamline the AD treatment pathway and reduce the burden on healthcare resources [1].

The FDA granted fast track status to Eisai's rolling submission of the Supplemental Biologics License Application (sBLA) for Leqembi Iqlik. The sBLA is based on the evaluation of SC lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE) study. The approval of the 500 mg SC dosing regimen (two 250 mg injections) as a weekly starting dose could significantly impact the management of AD, particularly in early stages [1].

Eisai and Biogen are co-commercializing and co-promoting Leqembi, with Eisai having final decision-making authority. The drug is currently approved in 48 countries and is under regulatory review in 10 countries. The approval of Leqembi Iqlik for maintenance dosing could further expand the market for the drug and potentially improve patient outcomes [1].

References:
[1] Eisai Co., Ltd. (2025). Eisai and Biogen Announce Rolling Submission of sBLA for Leqembi Iqlik for Maintenance Dosing in Early Alzheimer's Disease. Retrieved from https://www.eisai.com/news/2025/news202560.html