(Reuters) – Staff reviewers of the U.S. Food and Drug Administration (FDA) said on Wednesday that Eisai and Biogen’s Alzheimer’s drug, Leqembi, may still be eligible for a full approval despite concerns of brain hemorrhage from using blood thinners along with the drug.
The FDA staff’s comments about the drug were made in documents released ahead of a meeting of the panel of external advisers on Friday to discuss the Japanese company’s application for a traditional approval.
(Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Krishna Chandra Eluri, Shinjini Ganguli and Anil D’Silva)
