At-home injection version of Alzheimer’s drug now available in US
Patients can now skip infusions at hospital during early treatment
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In the U.S., people with early Alzheimer’s disease will now have the option for at-home treatment with the approved therapy Leqembi (lecanemab) throughout the entire treatment journey.
Leqembi is approved in the U.S. to treat early Alzheimer’s in adults with mild cognitive impairment or mild dementia. The originally approved version of the therapy is administered by infusion into the bloodstream every two weeks for 18 months, then every four weeks thereafter. These infusions typically need to be done at a hospital or infusion center.
Since the need for regular infusions can be burdensome for patients, Leqembi’s developers Biogen and Eisai have developed an under-the-skin injection version of the therapy, known as Leqembi Iqlik, which can be administered at home. Leqembi Iqlik is administered via an autoinjector, a device that automatically delivers a predetermined dose at the touch of a button.
Leqembi Iqlik can be used from start of treatment
About a year ago, the U.S. Food and Drug Administration (FDA) approved Leqembi Iqlik for use as maintenance therapy, giving patients an alternative after the initial 18 months of infusions. More recently, the FDA also authorized the under-the-skin formulation for use in initiation treatment during the first 18 months of therapy.
Under the new approval, during the first 18 months, Leqembi Iqlik is administered at a dose of 500 mg weekly. After 18 months, the therapy is given at a lower dose of 360 mg weekly.
A 360 mg autoinjector for weekly maintenance dosing was previously available, and now 250 mg autoinjectors are available for initial dosing. Since the recommended starting dose is 500 mg weekly, patients need to do two consecutive injections each week. Each injection takes about 15 seconds, according to a press release from Biogen and Eisai.
With both the original infusion version of Leqembi and Leqembi Iqlik now available for all stages of treatment in early Alzheimer’s, patients may switch between the two formulations at their convenience. For patients initiating this therapy, Biogen and Eisai offer resources, including a welcome kit and financial assistance for qualifying uninsured individuals.
Alzheimer’s is marked by clumps of a protein called amyloid-beta in the brain. The active ingredient in both Leqembi and Leqembi Iqlik is an antibody that’s designed to break up these clumps. FDA approval of Leqembi was based on data from the Phase 3 Clarity AD clinical trial (NCT03887455), which demonstrated that the therapy was superior to a placebo in slowing the decline in cognition and functional ability in patients with early Alzheimer’s.
Of note, both versions of Leqembi carry a risk for amyloid-related imaging abnormalities, or ARIA, which are side effects marked by swelling or bleeding in the brain. This usually doesn’t cause overt problems, but in rare cases it can be life-threatening. As such, patients on any formulation of Leqembi need to undergo regular MRI scans to monitor for ARIA.
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