The European Commission refers lecanemab decision to Appeal Committee
The European Commission refers lecanemab decision to Appeal Committee |
| [01-April-2025] |
STOCKHOLM, April 1, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee. The final process for the EC decision on lecanemab's Marketing Authorisation Application (MAA) is underway, following the reconfirmation of the positive opinion for lecanemab's approval by the Committee for Medicinal Products for Human Use (CHMP) in February 2025. The EC announced that it has deliberated on the MAA in its Standing Committee and, based on the results of those deliberations, has referred the decision to the Appeal Committee in accordance with the EC review process. If the marketing authorization application for lecanemab is approved, the approval will apply to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Leqembi is already approved in the US, Japan, China, Great Britain and other markets. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently, the two companies are preparing for a joint commercialization in the region. This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on April 1, 2025, at 12:00 CET. For further information, please contact: Charlotte af Klercker, Senior Director Sustainability and Communications About lecanemab (Leqembi®) Lecanemab is approved in the U.S., Japan, China, United Kingdom, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion in November 2024, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. Food and Drug Administration (FDA) in January 2025. In January 2025, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous auto injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S., with PDUFA date August 31, 2025. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai About BioArctic AB This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE BioArctic | ||||
Company Codes: Bloomberg:BIOAB@SS, ISIN:SE0010323311, RICS:BIOAB.ST, Stockholm:BIOA-B, Stockholm:BIOA-B.ST |
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