MedCity News September 2, 2025
Frank Vinluan

Injectable Leqembi permits weekly maintenance dosing of the Eisai and Biogen Alzheimer’s disease drug that may be done at a patient’s home. Other recent notable regulatory news includes several rare disease drug approvals and narrower FDA nods for Covid-19 vaccines.

The Eisai- and Biogen-partnered Alzheimer’s disease drug Leqembi has been available to date as an intravenous infusion that takes about an hour. Patients will soon have the option to choose an injectable version that can be dosed in 15 seconds.

The new FDA-approved injectable formulation is only for maintenance dosing; patients still must start with intravenously infused Leqembi every two weeks along with the standard monitoring that comes with it. But after 18 months, patients may switch to a new...

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