According to the Zhongtong Finance APP, Biogen (BIIB.US) and its Japanese partner, Esai (ESALF.US), announced on Thursday that their groundbreaking Alzheimer's disease treatment drug Leqembi (lecanemab) has obtained marketing authorization in the United Kingdom.
According to the Zhongtong Finance APP, Biogen (BIIB.US) and its Japanese partner, Esai (ESALF.US), announced on Thursday that their groundbreaking Alzheimer's disease treatment drug Leqembi (lecanemab) has obtained marketing authorization in the United Kingdom, making it the first country in Europe to approve the drug. This approval is mainly based on the Phase 3 data from Esai's Clarity AD clinical trial, which showed statistically significant results in achieving the primary and all key secondary endpoints.
This drug targets the underlying causes of Alzheimer's disease. Lecanemab is a humanized monoclonal antibody of immunoglobulin G1 and is said to be the only approved drug for the treatment of Alzheimer's disease. It can slow down the progression of the disease and delay cognitive and functional decline.
In the United Kingdom, lecanemab is used to treat mild cognitive impairment and mild dementia caused by Alzheimer's disease in adult patients who are carriers or non-carriers of apolipoprotein Eε4 (ApoEε4).
In January 2024, China approved Leqembi as a treatment for mild cognitive impairment and mild dementia caused by Alzheimer's disease, making it the third country to approve Leqembi after the United States and Japan.
Esai is the primary developer of the drug, with Biogen assisting in commercialization. The two companies will jointly promote the drug in the United Kingdom, with Esai as the marketing authorization holder distributing the product.
Earlier this month, Biogen released its second-quarter financial report and raised its full-year profit forecast. The second-quarter report showed that sales of Leqembi, the Alzheimer's disease drug developed in collaboration with Esai, were approximately $40 million, far exceeding the $19 million in the first quarter. As sales of Biogen's flagship multiple sclerosis drug decline, the company is seeking to boost sales of Leqembi.
Previously, the European pharmaceutical regulatory agency refused the drug, which was a setback for both companies. In July of this year, the American regulatory agency approved a competing Alzheimer's disease treatment drug from Eli Lilly and Co.