Shots:
- The US FDA has approved Tauklarify (florquinitau F 18 injection/ MK-6240) for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify pts with tau neurofibrillary tangle (NFT) pathology
- Approval was supported by Study 1 & 2 assessing Tauklarify (IV, 185 MBq) PET images from >500 pts who participated in 3 trials, where independent readers classified Tauklarify scans as positive or negative for tau NFT pathology against a standard
- Study 1 incl. 279 pts, with PPA ranging from 80 to 88%, NPA from 98 to 99%, & high inter-reader agreement (generalized Fleiss’ kappa 0.92). Study 2 incl. 338 pts, with PPA of 68 to 82%, NPA of 93 to 99%, & high inter-reader agreement (generalized Fleiss’ kappa 0.86)
Ref: Lantheus | Image: Lantheus | Press Release
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