FDA clears Lantheus’ tau imaging agent for Alzheimer’s use

Lantheus Holdings Inc. said on Tuesday the U.S. Food and Drug Administration (FDA) has approved its Posluma (flortaucipir F 18) injection for use as an imaging agent to estimate the density and distribution of tau pathology in the brains of adults with cognitive impairment who are being evaluated for Alzheimer’s disease.

The approval marks a step forward for diagnostic tools in Alzheimer’s care, as tau tangles are a hallmark of the neurodegenerative disorder. Posluma is designed to bind to tau protein aggregates in the brain, enabling physicians to assess disease progression through positron emission tomography (PET) scans.

Lantheus said the FDA granted approval based on data from clinical studies demonstrating the agent’s safety and efficacy in detecting tau pathology. The company plans to commercialize Posluma in the U.S. and expects to begin shipments to imaging centers in the coming weeks.

The imaging agent is not intended to diagnose Alzheimer’s disease on its own but to provide additional information alongside other clinical assessments. Lantheus has not disclosed pricing details for Posluma, though it noted that reimbursement discussions with payers are underway.

The approval comes as the Alzheimer’s drug development pipeline expands, with companies increasingly focusing on biomarkers to improve early detection and patient stratification. Lantheus’ Posluma joins a growing number of diagnostic tools aimed at addressing unmet needs in neurodegenerative disease management.