Biogen表示FDA延长了对Leqembi alloe注射剂的审查

2026-05-08 14:52

Biogen (BIIB) and Eisai (ESALF) Friday said that the FDA has extended its review by three months of the supplemental application for the Leqembi IQLIK subcutaneous injection as an initial treatment option for early Alzheimer’s disease, according to a joint statement.
The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026.
As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials.
The FDA has not raised any concerns to date regarding the approvability of Leqembi IQLIK as a starting dose, the company said.

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