{"id":55611,"date":"2026-01-27T17:49:52","date_gmt":"2026-01-27T09:49:52","guid":{"rendered":"https:\/\/flcube.com\/?p=55611"},"modified":"2026-01-27T17:49:53","modified_gmt":"2026-01-27T09:49:53","slug":"bioarctic-partner-eisai-submits-ema-application-for-four-week-lecanemab-dosing-in-alzheimers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55611","title":{"rendered":"BioArctic Partner Eisai Submits EMA Application for Four-Week Lecanemab Dosing in Alzheimer’s"},"content":{"rendered":"\n

BioArctic AB<\/strong> (OTCMKTS:\u202fBRCTF<\/a>) partner Eisai<\/strong> (TYO: 4523<\/a>) announced submission of a proposed Marketing Authorisation Variation<\/strong> to the European Medicines Agency (EMA)<\/strong> for a once every four weeks intravenous (IV) infusion maintenance dosing<\/strong> for lecanemab<\/strong> in Alzheimer\u2019s disease.<\/p>\n\n\n\n

Regulatory Submission & Dosing Change<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Companies<\/strong><\/td>BioArctic AB \/ Eisai<\/td><\/tr>
Submission<\/strong><\/td>Marketing Authorisation Variation to EMA<\/td><\/tr>
Drug<\/strong><\/td>Lecanemab (anti\u2011amyloid beta antibody)<\/td><\/tr>
Current Dosing<\/strong><\/td>IV infusion once every two weeks (10\u202fmg\/kg)<\/td><\/tr>
Proposed Dosing<\/strong><\/td>After 18\u202fmonths, transition to once every four weeks<\/td><\/tr>
Indication<\/strong><\/td>Mild cognitive impairment (MCI) or mild dementia due to Alzheimer\u2019s disease (early AD)<\/td><\/tr>
Patient Criteria<\/strong><\/td>ApoE\u202f\u03b54 non\u2011carriers or heterozygotes with confirmed amyloid pathology<\/td><\/tr>
Discontinuation<\/strong><\/td>Upon progression to moderate Alzheimer\u2019s disease<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Collaboration<\/h2>\n\n\n\n