Biotech
Friday, July 26th, 2024 2:21 pm EDT
Key Points
- European Rejection and Response: European regulators have rejected Biogen and Eisai’s Alzheimer’s drug, Leqembi, based on the European Medicines Agency’s committee’s recommendation. The committee cited concerns that the drug’s benefits in slowing cognitive decline do not outweigh the risks of serious side effects, including brain swelling and bleeding. Eisai has expressed strong disappointment and plans to seek a re-examination of the decision.
- Market Impact and Global Approvals: Following the rejection, Biogen’s stock fell nearly 5%, while Eisai’s stock remained relatively stable. Despite this setback in Europe, Leqembi has been approved by the U.S. Food and Drug Administration and other international regulatory bodies, including Japan, South Korea, China, and Israel. The drug’s rollout has been hampered by issues related to diagnostic tests and brain scans.
- Context and Comparisons: Leqembi and another monoclonal antibody, Kisunla from Eli Lilly, represent significant advancements in Alzheimer’s treatment, targeting amyloid plaques in the brain. However, both drugs face challenges due to serious side effects. The rejection of Leqembi in Europe follows the earlier failure of Biogen and Eisai’s Aduhelm, which was also rejected by European regulators in 2021. With Alzheimer’s affecting seven million people in Europe—expected to double by 2050—the ongoing search for effective treatments remains critical.
On Friday, European drug regulators rejected the Alzheimer’s treatment Leqembi, developed by Biogen and Eisai, presenting a significant setback for the companies as they attempt to increase the drug’s adoption in the U.S. The European Medicines Agency’s human medicines committee advised against granting marketing authorization for Leqembi, citing that its benefits in delaying cognitive decline do not outweigh the risks of serious side effects, including brain swelling and bleeding. This negative recommendation, which the European Commission is likely to follow, has left Eisai “extremely disappointed,” and the company plans to request a re-examination of the decision. Following the announcement, Biogen’s stock dropped nearly 5%, while Eisai’s shares remained relatively unchanged.
Leqembi, a monoclonal antibody designed to slow Alzheimer’s disease progression in its early stages, had previously received approval from the U.S. Food and Drug Administration and other regulatory bodies including Japan, South Korea, China, and Israel. However, its rollout has faced challenges, including delays related to diagnostic tests and regular brain scans. The drug’s rejection in Europe highlights ongoing difficulties in the Alzheimer’s treatment landscape, despite significant advancements.
The committee’s decision mirrors concerns seen with other similar treatments, such as Kisunla from Eli Lilly, which targets amyloid plaques in the brain but also carries risks of serious side effects. While Kisunla recently received U.S. approval, Leqembi’s fate in Europe is a major blow for Biogen and Eisai, following the earlier rejection of another Alzheimer’s drug, Aduhelm, by the European Medicines Agency in 2021. With seven million people currently living with Alzheimer’s in Europe—a number expected to double by 2050—effective treatments are desperately needed, underscoring the high stakes for drug developers in this field.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/07/26/biogen-eisai-alzheimers-drug-leqembi-rejected-by-european-regulator.html
