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FDA Approves New Alzheimer's Tau Scan
17 Aug
Summary
- FDA approved Lantheus Holdings' Tauklarify for tau pathology in Alzheimer's patients.
- The approval was based on studies showing high accuracy in identifying tau NFTs.
- Lantheus plans to assess commercial availability aligned with Alzheimer's therapeutic developments.
The U.S. Food and Drug Administration (FDA) has granted approval to Lantheus Holdings' Tauklarify, a radiodiagnostic agent for identifying tau pathology in adult patients undergoing evaluation for Alzheimer's disease. This innovative tool utilizes positron emission tomography (PET) imaging to detect tau neurofibrillary tangle (NFT) pathology, a key biomarker alongside amyloid-beta plaques.
The FDA's decision was underpinned by two blinded read studies involving over 500 participants, which confirmed Tauklarify's high accuracy and strong inter-reader agreement in pinpointing tau NFT pathology. These studies utilized Tauklarify PET images from individuals with varying cognitive statuses, including those with mild cognitive impairment and mild Alzheimer's disease dementia.
With this clearance, Lantheus Holdings is poised to support Alzheimer's disease therapeutic programs and will carefully assess the optimal path for Tauklarify's commercial rollout. The company emphasizes that its approach will be guided by partner needs and the dynamic advancements within the Alzheimer's disease treatment sector. CEO Mary Anne Heino highlighted the growing importance of tau imaging in Alzheimer's assessment.
This approval arrives amidst significant developments in Alzheimer's diagnostics, including the recent FDA clearance of blood-based biomarker tests like Roche's Elecsys pTau181 and pTau217. Furthermore, the landscape has been shaped by the 2023 and 2024 FDA approvals of disease-modifying therapies such as Leqembi and Kisunla, with blockbuster potential anticipated in the coming years.
