Eisai starts rolling application for US approval of under-the-skin Leqembi

Developer allowed to do FDA submission in parts instead of when completed

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Eisai has started a rolling application seeking U.S. approval of a subcutaneous, or under-the-skin, injection version of Leqembi (lecanemab) for maintenance dosing in people with early Alzheimer’s disease.

This formulation of the approved intravenous (into-the-vein) medication is expected to reduce the treatment burden for patients, if granted approval by the U.S. Food and Drug Administration (FDA).

With a rolling application, Eisai is allowed to submit individual sections of the application to the FDA as they are ready, rather than having to wait until the entire application is finished, as is normally done. This change typically allows a developer earlier and more frequent communication with regulators, which can help to speed a drug’s approval. The application has been granted fast track designation, which shortens the review process.

Eisai and Biogen, Leqembi’s co-developers, did not specify in their announcement when the application is expected to be finished or when a decision from the FDA is anticipated.

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A clinician gives a patient a subcutaneous or under-the-skin injection.

Under-the-skin formulation seen to work better than approved Leqembi

Leqembi approved in US last year as into-the-vein treatment

Leqembi last year won full approval from the FDA as an intravenous therapy. Treatment is specifically indicated for Alzheimer’s patients who have mild cognitive impairment or are in mild stages of dementia.

Under the current approval, Leqembi is administered via infusions into the bloodstream every other week. Each infusion lasts an hour and needs to be done under the supervision of a healthcare provider.

Last month, Eisai announced it was seeking FDA approval for a once-monthly infusion of Leqembi as a maintenance therapy for patients who have completed the initial every-other-week regime.

With this new rolling biologics license application, Eisai also is asking the FDA to approve a subcutaneous (under-the-skin) autoinjector version of Leqembi for maintenance dosing. The subcutaneous version would be given as weekly injections.

Subcutaneous injections have a few notable advantages over infusions. First, they don’t take as long to administer. Eisai and Biogen did not specify exactly how long each injection would take, but said the process of giving an injection takes less time overall than the infusion version.

Also of possible benefit for patients, while infusions need to be given under the guidance of a professional, subcutaneous injection therapies often can be administered at home by patients or caregivers who have received appropriate training. According to Eisai and Biogen, the subcutaneous autoinjector “could be used to administer Leqembi at home or at medical facilities.”

“Subcutaneous maintenance dosing may be more convenient for patients and their care partners to continue the treatment,” the companies stated.

The rolling application for subcutaneous Leqembi is based on data from the open-label extension of the Phase 3 Clarity AD trial (NCT03887455). That study served as the basis for Leqembi’s initial FDA approval after showing that the therapy slowed decline in measures of cognition and functional ability relative to a placebo.

A sub-study from the Clarity trial compared weekly subcutaneous Leqembi against the approved dosing schedule of every-other-month infusions, with the results indicating that the subcutaneous version led to better clearance of beta-amyloid plaques. Leqembi is designed to break up clumps in the brain of the beta-amyloid protein — a molecular hallmark of Alzheimer’s that’s believed to play a central role in driving the disease.

In addition to the U.S., Leqembi is approved in China and Japan, and it’s being considered for approval in the European Union and more than a dozen other countries worldwide.