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FDA: subcutaneous lecanemab can now be used to initiate treatment, agency tells NAPA
Summary
An FDA official told the council that on July 16 the FDA approved a subcutaneous formulation of lecanemab for initiation of Alzheimer's treatment, removing the prior requirement of 18 months of IV infusions before using the subcutaneous form.
At a federal‑agency update, an FDA representative announced that on July 16 the agency approved a subcutaneous formulation of lecanemab for initiation of treatment for Alzheimer's disease. "On July 16, FDA approved, the subcutaneous form of Lekanumab for initiation of treatment, for Alzheimer's disease," the official said, noting the change from previous maintenance‑only subcutaneous use.
The speaker explained the regulatory implication: previously patients had to receive 18 months of IV infusions before moving to subcutaneous dosing; with the approval, clinicians may initiate therapy using the subcutaneous route per the product label and standard clinical decision‑making. The council reaction was brief and positive; the update was delivered as an oral agency comment during the federal‑agency segment of the meeting.
