NEW YORK – The European Commission will resume its review of Eisai and Biogen's marketing authorization application for their anti-amyloid Alzheimer's disease drug Leqembi (lecanemab), the companies said Friday.
Earlier this year, the EC requested that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) consider safety data on Leqembi that became available after the committee had adopted a positive opinion on the drug in November. The November opinion reversed a previous recommendation against the drug from July.
The EC, which considers the CHMP's opinion in deciding whether to grant a drug marketing authorization in the EU, asked the committee to consider whether the new safety data required an update to its opinion or wording of risk minimization measures it included in the opinion.
Now, the CHMP has reaffirmed its positive opinion for Leqembi, without updates, and the EC will resume its process to review the drug's marketing authorization application.
If the EC approves the application, the approval for Leqembi will apply to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Tokyo-based Eisai serves as the lead for Leqembi's development and regulatory submissions globally, while Eisai and Cambridge, Massachusetts-based Biogen co-commercialize and co-promote the product. Eisai retains final decision-making authority for the drug.