Lantheus Announces FDA Acceptance of New Drug Application for MK-6240, a PET Imaging Agent Targeting Tau in Alzheimer’s Disease

Core Insights - The FDA has accepted Lantheus Holdings' New Drug Application for MK-6240, a PET imaging agent for detecting tau pathology in Alzheimer's disease, with a PDUFA target action date set for August 13, 2026 [1][2] Company Overview - Lantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative diagnostic tools [6] - The company has been providing radiopharmaceutical solutions for nearly 70 years and operates in multiple countries including the U.S., Canada, Germany, Sweden, Switzerland, and the U.K. [6] Product Details - MK-6240 targets aggregated tau protein, a key marker in neurodegenerative diseases, and has shown high affinity for tau with limited off-target binding in studies [5] - The NDA submission for MK-6240 is supported by data from two pivotal Phase 3 clinical trials that met their co-primary endpoints of sensitivity and specificity for detecting tau neurofibrillary tangles [2][5] Market Potential - The U.S. Alzheimer's Disease radiodiagnostic market is projected to exceed 400,000 scans and reach $1.5 billion by 2030, driven by rising prevalence and expanded PET imaging guidelines [4] - There are nearly 12 million people in the U.S. living with mild cognitive impairment or Alzheimer's disease, with projections indicating this number could grow to over 20 million by 2050 [3]