The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for Enigma Biomedical USA’s (EB USA) MK-6240 (florquinitau F-18) tau PET imaging radiodiagnostic.
MK-6240, which was previously granted fast-track status by the FDA, is designed to target aggregated tau protein in the form of tau neurofibrillary tangles (NFTs), a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026, according to EB USA.
Lantheus Medical Imaging acquired the rights to MK-6240 in 2023, engaging EB USA’s team to work on the PET tracer's development.
In April, Lantheus announced that MK-6240 had met its co-primary endpoints in two trials assessing its sensitivity and specificity. The trials provided data to support the NDA.
EB USA noted that it is also collaborating with AbbVie on the development of novel 4R tau PET imaging biomarkers.
