BRIEF-U.S. FDA APPROVES EISAI, BIOGEN'S SECOND ALZHEIMER'S DRUG

Jan 6 (Reuters) - U.S. FDA:

• U.S. FDA APPROVES EISAI, BIOGEN'S SECOND ALZHEIMER'S DRUG

• U.S. FDA SAYS LEQEMBI WAS APPROVED USING THE ACCELERATED APPROVAL PATHWAY

• U.S. FDA SAYS PRESCRIBING INFORMATION FOR LEQEMBI INCLUDES WARNING FOR AMYLOID-RELATED IMAGING ABNORMALITIES

• U.S. FDA SAYS MOST COMMON SIDE EFFECTS OF LEQEMBI WERE INFUSION-RELATED REACTIONS, HEADACHE AND ARIA

• U.S. FDA - LABELING STATES THAT TREATMENT WITH LEQEMBI SHOULD BE INITIATED IN PATIENTS WITH MILD COGNITIVE IMPAIRMENT OR MILD DEMENTIA STAGE OF DISEASE

Further company coverage: 4523.T

((Reuters.Briefs@thomsonreuters.com;))