Research company Bioarctic has announced that the U.S. Food and Drug Administration (FDA) has extended its review of Leqembi Iqlik as a maintenance dose for the treatment of early Alzheimer's disease. The new PDUFA date has been set for August 24, shifting from the previous target for a decision in May.

Bioarctic's partner, Eisai, stated that the FDA requested additional information, which has been classified as a major amendment to the application. According to the company, the agency has not raised any objections regarding the potential for approval at this stage.

Leqembi Iqlik is a subcutaneous formulation of Leqembi.