Eisai Co. Ltd (ESALY.PK) and Biogen Inc. (BIIB) on Friday said the U.S. Food and Drug Administration has extended by three months the review of LEQEMBI IQLIK as a starting dose for the treatment of early Alzheimer's disease.
The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026.
The FDA requested additional information during the review process and has not raised any concerns about the drug's approvability as a starting dose, the companies said.
LEQEMBI has been approved in more than 50 countries for the treatment of early Alzheimer's disease.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.