Eisai begins US FDA rolling submission for Alzheimer’s drug Leqembi

Japanese drugmaker Eisai, in partnership with Biogen, have announced that they have begun submitting data on a rolling basis to the US FDA for a marketing application of a subcutaneous injectable form of Alzheimer’s drug Leqembi. 

Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody (mAb) for the treatment of Alzheimer’s disease. In January 2023, it was granted accelerated approval by the US FDA. Leqembi targets the fundamental pathophysiology of the disease, and has demonstrated statistically significant reductions in brain amyloid plaque in patients with mild cognitive impairment and confirmed presence of amyloid beta pathology. Amyloid beta deposits are a histopathological hallmark of Alzheimer’s disease. Currently, it is administered via intravenous infusion bi-weekly. 

In April, Eisai delayed filing for marketing approval of a subcutaneous form of Leqembi when the FDA requested 3-month additional immunogenicity data. The hope is that, should the subcutaneous form be approved, patients can be treated at home or at non-clinical medical facilities as it is less invasive and time-consuming than the intravenous formulation. The intravenous formulation also requires certain pre-requisites from patients, such as additional diagnostic tests and twice-monthly infusions and regular brain scans.  

Sales of Leqembi are projected to increase 13-fold in 2024 from the fiscal year-end of March. Eisai plans to launch Leqembi in China in July, and expects most sales growth to come from the US market. 

Source: 

Eisai starts rolling submission for injectable version of Alzheimer’s drug with US FDA [Accessed May 15, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/eisai-starts-rolling-submission-injectable-version-alzheimers-drug-with-us-fda-2024-05-14/