Biogen (BIIB) and Eisai said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use reaffirmed its positive opinion on lecanemab for early Alzheimer's disease, allowing the European Commission to resume its review of the drug's marketing application.
The companies said the European Commission had asked the committee to reassess lecanemab's safety data and risk minimization measures after issuing its initial opinion in November. The committee determined that no changes were needed, according to the joint statement.
Eisai leads the drug's global development and regulatory process, with Biogen co-commercializing and co-promoting it, the companies said.
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