On Friday, the U.S. Food and Drug Administration (FDA) approved Lantheus Holdings Inc.’s (NASDAQ:LNTH) Tauklarify (florquinitau F 18 injection).
Also known as MK-6240, this radiodiagnostic agent is designed for positron emission tomography (PET) scans of the brain in adult patients experiencing cognitive impairment who are undergoing evaluation for Alzheimer’s disease.
The agent helps identify patients with tau neurofibrillary tangle (NFT) pathology.
The company noted a limitation of use, stating that Tauklarify’s safety and effectiveness in evaluating non-Alzheimer’s disease tauopathies have not been established.
Supporting Clinical Programs And Commercial Paths
Following FDA approval, Lantheus plans to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business.
The company is also evaluating the appropriate strategy for broader commercial availability. Lantheus stated its approach would remain consistent with its partners’ needs and be guided by developments within the Alzheimer’s disease treatment sector.
Blinded Read Studies Support Approval
The FDA’s decision was supported by two studies, Study 1 and Study 2, which analyzed Tau-PET images from over 500 subjects across three clinical trials.
These trials encompassed individuals with mild cognitive impairment, mild Alzheimer’s disease dementia, and those who were cognitively unimpaired. This allowed for evaluation across a wide range of cognitive function, including the disease’s earlier stages.
In Study 1, involving 279 subjects, the Positive Percent Agreement (PPA) across readers ranged from 80% to 88%, while the Negative Percent Agreement (NPA) ranged from 98% to 99%.
Study 2, analyzing images from 338 subjects, showed a PPA ranging from 68% to 82% and an NPA ranging from 93% to 99%. Both studies demonstrated high inter-reader agreement.
LNTH Stock Price Activity: Lantheus Holdings shares were down 0.02% at $101.00 at the time of publication on Friday, according to Benzinga Pro data.
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