FDA Offers Full Approval on Alzheimer’s Treatment Leqembi

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Biogen Inc., a biotechnology company, and Eisai Co., Ltd., a healthcare organization have announced the traditional FDA approval of Leqembi, making it the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease. Reportedly, clinical trials demonstrated significant slowing of cognitive and functional decline in patients with mild dementia.

“Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable. We would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible,” said Christopher A. Viehbacher, president, CEO, Biogen. "Our focus is now on the path forward, working alongside Eisai with the goal of making LEQEMBI accessible to eligible patients as soon as possible.”

Reference: FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease. GlobeNewswire. July 6, 2023. Accessed July 7, 2023. https://www.globenewswire.com/news-release/2023/07/07/2700886/0/en/FDA-Grants-Traditional-Approval-for-LEQEMBI-lecanemab-irmb-for-the-Treatment-of-Alzheimer-s-Disease.html