Welcome to “A to Z: Drugs in Highlight:
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
L is for LEQEMBI®
LEQEMBI® (from Eisai GmbH) uses lecanemab for treating early Alzheimer’s disease in apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. It is particular for those patients with a clinical diagnosis of mild cognitive impairment and mild dementia. It is available as a 100 mg/mL injection for intravenous use.
How it works:
LEQEMBI® contains the active substance lecanemab. Lecanemab is a monoclonal antibody that targets and binds to both soluble and insoluble aggregated forms of amyloid beta, thereby effectively reducing beta plaques in the brain. The primary benefit of LEQEMBI® is its ability to slow the progression of cognitive and functional deficits associated with Alzheimer’s disease.
Marketing approval:
LEQEMBI® is approved for marketing in the United States (approved by the FDA in January 2023).
As part of its decision-making process, the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to inter alia consider information on the safety of LEQEMBI® that became available after the adoption of the CHMP opinion in November 2024 and whether this opinion may require an update of the opinion. The CHMP will consider the Commission’s request and provide a response after its plenary meeting in February 2025.
Patent protection:
LEQEMBI® is the result of a long-standing collaboration between BioArtic and Eisai. The antibody was originally developed by BioArtic based on the work of Professor Lars Lannfelt. There are patent rights protecting various aspects of LEQEMBI® (in the name of BioArtic) in the United States and Europe. For example:
European patent no. 2448968 includes claims that functionally define lecanemab. Granted claim 1 relates to an antibody, wherein the antibody is raised against stabilized protofibril comprising the N-terminal truncated Amyloid beta (Aβ) Aβ3(pE)-42, and is selected such that it (i) binds soluble protofibril comprising Aβ3(pE)-42, (ii) binds Aβ3(pE)-42 monomer, and (iii) exhibits no or substantially no binding with non-N-terminal truncated Aβ monomer, wherein: (a) the non-N-terminal truncated Aβ monomer may or may not have a C-terminal truncation; and (b) the stabilized protofibril is stabilized with a hydrophobic organic agent comprising a non-ionic detergent, a zwitterionic detergent, 4-hydroxy-2-nonenal (HNE), or 4-oxo-2-nonenal (ONE), and wherein the stabilized protofibril has a lower formation rate to a non-soluble aggregated form than a non-stabilized form of the protofibril.
The equivalent United States patent application is still in examination and uses a similar functional definition for lecanemab.
Patent support from Secerna
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