FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The U.S. Food and Drug Administration has accepted an application for a new Alzheimer’s PET imaging agent from Lantheus, the company announced Tuesday.
This comes after the North Billerica, Massachusetts-based drugmaker recently announced positive results from two “pivotal” studies. Lantheus is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
The product has successfully met primary endpoints pertaining to both sensitivity and specificity. Data from the experiments will support Lantheus’ New Drug Application, with the FDA potentially reaching a decision by August 2026, if all goes as planned.
“We’re pleased the FDA has accepted our Fast Track application for MK-6240, highlighting the urgent need for innovative Alzheimer’s diagnostic tools and the potential of MK-6240 to meet that need…,” Lantheus CEO Brian Markison said in an Oct. 28 announcement. “If approved, MK-6240 would complement beta-amyloid PET imaging and emerging blood-based diagnostics, helping guide treatment strategies for providers and patients,” he added later.
Markison noted there are over 100 disease-modifying therapies in development for the Alzheimer’s. They include about 30 targeting tau pathologies (with MK-6240 one of them), and another 40 relating to beta amyloid. Currently, nearly 12 million individuals are living with mild cognitive impairment from the disease. As the population ages, prevalence will continue to rise. Given such growth, the U.S. Alzheimer’s disease radiodiagnostic market has the potential to reach over 400,000 scans and $1.5 billion by 2030, Lantheus noted.
MK-6240 is designed to targeted aggregated tau protein in the form of neurofibrillary tangles, a sign of several neurodegenerative diseases. It has demonstrated a high affinity for tau and limited off-target binding in key clinical studies, the company noted. Lantheus acquired the drug in 2023, and it previously received Fast Track designation, currently being used in nearly 100 active clinical trials.
“We anticipate that MK-6240 will support earlier disease detection, patient staging, therapy selection, and monitoring, and may help enable tau to serve as a surrogate endpoint for treatment efficacy,” Lantheus noted in its announcement.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.