-+undefined NaN%
-+undefined NaN%
-+undefined NaN%

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

Reuters · 01/06/2023 14:15
BRIEF-U.S. FDA APPROVES EISAI, BIOGEN'S SECOND ALZHEIMER'S DRUG

- 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;))