Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for an injectable formulation of their Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb).
The anti-amyloid drug was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD.
The companies are now seeking approval of their Leqembi subcutaneous (SC) autoinjector for weekly maintenance dosing in patients who have completed the bi-weekly IV initiation phase, with the injection process expected to take 15 seconds on average.
If approved by the regulator, which is expected to make a decision by 31 August, Leqembi will be the only AD treatment that can be given subcutaneously at home using an autoinjector.
The BLA filed by Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, is supported by positive results from the Clarity AD open-label extension of Leqembi, as well as modelling of observed data.
Results presented at the 2023 Clinical Trials on Alzheimer’s Disease conference from the SC sub-study showed that weekly SC administration of Leqembi removed 14% more amyloid plaque than the approved IV formulation after six months of treatment.
Affecting more than 6.5 million people in the US, AD is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
“The SC autoinjector is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and may contribute to further simplifying the treatment pathway for AD,” the companies said in a statement.
The FDA has also accepted a supplemental BLA for monthly Leqembi IV maintenance dosing, with a decision expected by 25 January.
The latest announcement for the drug comes two months after it was recommended by the European Medicines Agency’s human medicines committee to treat adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD who have one or no copies of the apolipoprotein E4 gene.