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Diseases

Lantheus Holdings Announces FDA Acceptance of New Drug Application for MK-6240 Tau-Targeted Imaging Agent

Strategic Insights

— 2 min read

Lantheus Holdings, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, a radiopharmaceutical diagnostic for detecting tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer's disease. This approval follows the company's receipt of Fast Track designation for the agent's potential to address an unmet medical need in Alzheimer's disease diagnostics.

Key Takeaways:

  • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026, for Lantheus' NDA submission for MK-6240.
  • The NDA submission is supported by data from two pivotal Phase 3 clinical trials, which evaluated MK-6240's performance in detecting tau pathology in early Alzheimer's disease.
  • The agent has demonstrated a high affinity for tau and limited off-target binding in both preclinical and clinical studies.
  • MK-6240 has previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer's disease diagnostics.
  • Lantheus expects MK-6240 to support earlier disease detection, patient staging, therapy selection, and monitoring, and may help enable tau to serve as a surrogate endpoint for treatment efficacy.

Statistics:

  • The U.S. Alzheimer's Disease radiodiagnostic market has the potential to reach over 400,000 scans and $1.5 billion by 2030.
  • There are nearly 12 million people living with mild cognitive impairment or Alzheimer's disease in the U.S.
  • By 2050, the number of people 65 and older with mild cognitive impairment and Alzheimer's disease may grow to more than 20 million.
  • Lantheus has acquired MK-6240, which had previously received Fast Track designation and is currently being used in nearly 100 active clinical trials.

Sources:

  • Lantheus Holdings, Inc. press release, October 28, 2025 (GLOBE NEWSWIRE)
  • 1. Alzheimer's Association. 2024 Alzheimer's Disease Facts and Figures. Alzheimer's Dement 2024;20(5).
  • 2. Addressable market based on current management estimates, internal data, and current WAC / 340B pricing.
  • 3. Krishnadas N, Dore V, Robertson JS, Ward L, Fowler C, Masters CL, Bourgeat P, Fripp J, Villemagne VL, Rowe CC. Rates of regional tau accumulation in ageing and across the Alzheimer's disease continuum: an AIBL 18F-MK-6240 PET study. EBioMedicine. 2023 Feb;88:104450. doi: 10.1016/j.ebiom.2023.104450. Epub 2023 Jan 27. PMID: 36709581; PMCID: PMC9900352.
  • 4. Lohith TG, Bennacef I, Vandenberghe R, Vandenbulcke M, Salinas CA, Declercq R, Reynders T, Telan-Choing NF, Riffel K, Celen S, Serdons K, Bormans G, Tsai K, Walji A, Hostetler ED, Evelhoch JL, Van Laere K, Forman M, Stoch A, Sur C, Struyk A. Brain imaging of Alzheimer dementia patients and elderly controls with 18F-MK-6240, a PET tracer targeting neurofibrillary tangles. J Nucl Med. 2019 Jan;60(1):107-114. doi: 10.2967/jnumed.118.208215. Epub 2018 Jun 7. PMID: 29880509.

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