Eisai obtains FDA green light for Leqembi
BioArctic AB’s partner Eisai has obtained the green light from the Food and Drug Administration for Leqembi (lecanemab-irmb) 100 mg/ml injection for intravenous use, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta for the treatment of Alzheimer’s disease.
Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease, the FDA said.
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The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials. The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
"The FDA's approval of Leqembi under the Accelerated Approval pathway is an important milestone not only for BioArctic and our partner Eisai, but for the whole field as well as for patients, families and caregivers who can now benefit from the more than 20 years of research and development that lies behind this achievement. We are impressed by our partner Eisai's excellent work with Leqembi and are proud of our long-standing relationship that has led us to today's announcement," said Gunilla Osswald, CEO at BioArctic.
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"Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones," said Billy Dunn, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. "This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease."