FDA grants traditional approval for Leqembi for the treatment of Alzheimer's disease
BioArctic AB's partner Eisai has received the Food and Drug Administration’s traditional approval of Leqembi (lecanemab-irmb) 100 mg/ml injection for intravenous use, making Leqembi the only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease, the company said.
In conjunction with the approval, the Centers for Medicare and Medicaid Services announced that Medicare will provide broad coverage of Leqembi according to the FDA-approved label provided that real-world evidence is collected in an easy-to-use patient registry.
"The full, traditional approval of Leqembi in the United States, combined with the broad Medicare reimbursement, is a paradigm-shifting step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic. "Doctors in the United States will now have a tool to combat this terrible chronic disease already at an early stage, with the potential to provide clinically meaningful benefit for patients and their families. More than two decades of research and development has led up to this moment, and I am impressed by the diligent efforts of our partner Eisai to ensure that this important innovation can now reach the patients BioArctic was founded to serve. I am full of gratitude and hope for the future."
[Read more: Eisai obtains FDA green light for Leqembi]
"More than 25 years after my initial discoveries, it is fantastic to finally see Leqembi becoming available to the patients who have always been my focus," said Professor Lars Lannfelt, co-founder of BioArctic and inventor of Leqembi. "From the start, my idea was to find a way to clear the soluble amyloid beta oligomers and protofibrils, the most neurotoxic forms of Aβ, that continuously accumulate in the brain of Alzheimer disease patients. Leqembi was generated to do just that. But even if this is a great step forward, it is important for BioArctic and others to continue research to provide more options for patients."
[Read more: CVS Health to collaborate with Biogen for Alzheimer’s screenings]
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.