Leqembi IV monthly maintenance dosing approved by FDA
Eisai also seeking approval for weekly subcutaneous formulation
The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease.
The decision follows a supplemental application from Eisai, which is codeveloping Leqembi with Biogen, based on the modeling of data from the Phase 2 Study 201 (NCT01767311) and the Phase 3 Clarity AD study (NCT03887455), and their long-term extension studies, showing that once-monthly dosing can help sustain the therapy’s beneficial effects.
“The approval of once every four-week maintenance dosing of Leqembi is an important step forward in improving the care and quality of life for people living with early Alzheimer’s disease, as well as their caregivers,” George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, said an organization press release. “We are hopeful that this milestone will drive further innovation and increase access to treatments that ease the burden on both patients and their caregivers facing this devastating disease.”
Alzheimer’s is characterized by the accumulation of toxic clumps of the protein amyloid-beta in the brain, which are thought to contribute to neurodegeneration and disease symptoms.
Given as intravenous (into-the-vein) injections, Leqembi is an antibody designed to bind and neutralize amyloid-beta protofibrils, the most neurotoxic form of the protein, which is expected to slow disease progression.
Treatment to slow cognitive impairment, dementia progression
It is approved for use in people with mild cognitive impairment or mild dementia and evidence of amyloid-beta accumulation in the brain, at a dose of 10 mg/kg of body weight, once every two weeks. The treatment was shown to slow cognitive impairment and dementia progression and ease the accumulation of amyloid-beta in the brain.
However, even after amyloid-beta clumps are removed from the brain, protofibrils may still cause neuronal damage. Continuing treatment at the once-monthly maintenance dose is meant to maintain clinical benefits, at a dosing regimen that may cause less burden for patients and caregivers.
Data from Study 201 demonstrated that stopping Leqembi treatment led to a reaccumulation of amyloid-beta in the brain and reversal of cognitive benefits.
The now-approved regimen means patients who have completed the twice-monthly Leqembi initiation phase would transition to a once-monthly dosing regimen to maintain clearance of amyloid-beta.
“Frequent visits to the clinic or treatment center can be burdensome, and the once every four-week dosing regimen allows a much-needed reduction in that strain, making it easier for families to stay on track with treatment and extend the benefits of therapy,” Vradenburg said.
Eisai is also seeking FDA approval for a weekly subcutaneous (under-the-skin) formulation of Leqembi. Subcutaneous injections are faster than intravenous infusions and may be given at home by patients or caregivers after appropriate training.
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