FDA fast-tracks expanded home injections for Alzheimer’s drug Leqembi
Patients are first given therapy as infusions for 18 months under current approval
Written by |
The U.S. Food and Drug Administration (FDA) is reviewing an application seeking expanded approval of an under-the-skin injection version of Leqembi (lecanemab), called Leqembi Iqlik.
Leqembi is an approved treatment for early Alzheimer’s disease. Under its current approval, patients are first given the therapy as infusions into the bloodstream every other week for 18 months. Patients can then switch to infusions every four weeks or weekly subcutaneous (under-the-skin) injections. The infusions need to be given under the direction of a healthcare professional, while the subcutaneous injections can be given at home by caregivers or patients themselves.
Leqembi’s developers, Biogen and Eisai, are now asking the FDA to approve the weekly subcutaneous injection version of Leqembi for patients who are beginning treatment — meaning that patients on Leqembi would have the option to use this version throughout the entire treatment journey, rather than needing to do infusions for the first 18 months.Â
If the FDA approves this expansion, it “would enable patients and care partners to choose [subcutaneous] administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of [subcutaneous] or [infusion] administration throughout the entire treatment journey,” according to a press release from Biogen and Eisai.
The FDA has granted the companies’ application priority review, which shortens the review time by several months. A decision is expected by May 24.
Leqembi clears protein clumps from brain
In Alzheimer’s disease, abnormal clumps of a protein called beta-amyloid form in the brain. These clumps are toxic to nerve cells and are thought to play a key role in driving the disease. Leqembi is an antibody-based therapy that’s designed to clear amyloid-beta clumps from the brain, thereby slowing disease progression.
The original FDA approval of Leqembi in 2023 was largely based on data from a Phase 3 clinical trial called Clarity AD (NCT03887455), which tested the therapy against a placebo in patients with early Alzheimer’s and showed that Leqembi significantly slowed a measure of cognitive decline after 1.5 years.
Bioen and Eisai’s new application includes data from sub-studies conducted as part of an open-label extension to the Clarity AD study, conducted after the original placebo-controlled part of the study. These data showed that the weekly subcutaneous formulation of Leqembi delivered amounts of the drug comparable to those of the approved every-other-week infusion. Clinical, biomarker, and safety data were also comparable between the two formulations.
According to Biogen and Eisai, Leqembi has been approved in 53 countries worldwide and is currently under review in another seven.
