UK Approves Leqembi for Long-Term Alzheimer's IV Treatment
BioArctic AB, through its partner Eisai, has recently achieved a significant milestone with the approval of Leqembi (lecanemab) for maintenance intravenous (IV) treatment in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) granted this approval for once every four weeks dosing, offering a vital option for patients combating early-stage Alzheimer's disease.
This decision marks an important step forward for those diagnosed with mild cognitive impairment (MCI) and mild dementia linked to Alzheimer's, particularly for individuals identified as apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Leqembi was first approved in August 2024 for treating these cognitive conditions and has now expanded its serviceability to include long-term, less frequent dosing.
Patients previously treated with a regimen of 10 mg/kg every two weeks for 18 months can now either transition to a maintenance plan of 10 mg/kg every four weeks or continue with their current dosing schedule. In a country where approximately 982,000 individuals are living with dementia, with Alzheimer's accounting for about 60-70% of these cases, this approval is especially timely, given the pressing health implications as the aging population increases.
Leqembi's journey to approval is rooted in a long-term collaboration involving BioArctic and Eisai. The antibody itself was developed from research led by Professor Lars Lannfelt, who discovered the Arctic mutation associated with Alzheimer's disease. Eisai is accountable for steering clinical developments, securing market approvals, and commercializing Leqembi worldwide, while BioArctic retains the rights for commercialization specifically in the Nordic region.
With the recent approval, Leqembi has now been sanctioned in 51 countries globally, including key markets like the U.S., Japan, and the European Union, highlighting its pivotal role in combating early Alzheimer's disease. The efficacy of Leqembi is supported by data from Phase 3 trials conducted under the Clarity AD clinical study, which demonstrated statistically significant outcomes across cognitive and functional benchmarks, including the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Notably, the Leqembi Iqlik™ is set to further enhance treatment options with subcutaneous dosing approved in the U.S. With ongoing studies such as the AHEAD 3-45 clinical trial focusing on individuals exhibiting early indicators of Alzheimer's, the horizon appears promising for continued advancements in the field.
BioArctic, founded in 2005, remains at the forefront of research into neurodegenerative diseases, with its portfolio extending beyond Alzheimer's treatments to include initiatives targeting Parkinson's disease and ALS. Their innovative BrainTransporter™ technology specifically aims to facilitate the transport of antibodies across the blood-brain barrier, potentially augmenting therapeutic effectiveness.
As the approval process moves forward, BioArctic and Eisai are poised to broaden their impact in the Nordic markets. The strong foundation of collaboration and joint efforts ensure that both companies are well-prepared for effective commercialization of Leqembi and its critical role in treating Alzheimer's disease. With the mounting rates of dementia expected to rise alongside an aging population, treatments like Leqembi will be integral to addressing these public health challenges effectively.
This decision marks an important step forward for those diagnosed with mild cognitive impairment (MCI) and mild dementia linked to Alzheimer's, particularly for individuals identified as apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Leqembi was first approved in August 2024 for treating these cognitive conditions and has now expanded its serviceability to include long-term, less frequent dosing.
Patients previously treated with a regimen of 10 mg/kg every two weeks for 18 months can now either transition to a maintenance plan of 10 mg/kg every four weeks or continue with their current dosing schedule. In a country where approximately 982,000 individuals are living with dementia, with Alzheimer's accounting for about 60-70% of these cases, this approval is especially timely, given the pressing health implications as the aging population increases.
Leqembi's journey to approval is rooted in a long-term collaboration involving BioArctic and Eisai. The antibody itself was developed from research led by Professor Lars Lannfelt, who discovered the Arctic mutation associated with Alzheimer's disease. Eisai is accountable for steering clinical developments, securing market approvals, and commercializing Leqembi worldwide, while BioArctic retains the rights for commercialization specifically in the Nordic region.
With the recent approval, Leqembi has now been sanctioned in 51 countries globally, including key markets like the U.S., Japan, and the European Union, highlighting its pivotal role in combating early Alzheimer's disease. The efficacy of Leqembi is supported by data from Phase 3 trials conducted under the Clarity AD clinical study, which demonstrated statistically significant outcomes across cognitive and functional benchmarks, including the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Notably, the Leqembi Iqlik™ is set to further enhance treatment options with subcutaneous dosing approved in the U.S. With ongoing studies such as the AHEAD 3-45 clinical trial focusing on individuals exhibiting early indicators of Alzheimer's, the horizon appears promising for continued advancements in the field.
BioArctic, founded in 2005, remains at the forefront of research into neurodegenerative diseases, with its portfolio extending beyond Alzheimer's treatments to include initiatives targeting Parkinson's disease and ALS. Their innovative BrainTransporter™ technology specifically aims to facilitate the transport of antibodies across the blood-brain barrier, potentially augmenting therapeutic effectiveness.
As the approval process moves forward, BioArctic and Eisai are poised to broaden their impact in the Nordic markets. The strong foundation of collaboration and joint efforts ensure that both companies are well-prepared for effective commercialization of Leqembi and its critical role in treating Alzheimer's disease. With the mounting rates of dementia expected to rise alongside an aging population, treatments like Leqembi will be integral to addressing these public health challenges effectively.
Topics Health）
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