US medical device and life sciences giant GE Healthcare Technologies Inc., (NASDAQ: GEHC) announced that the U.S. Food and Drug Administration (FDA) has approved a label update for its positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F18), used for detecting beta-amyloid plaques.
Label Update Details
Originally approved in 2013 for assessing beta-amyloid neuritic plaque density in adult patients with cognitive impairment being evaluated for Alzheimer’s disease (AD), the revised label expands Vizamyl’s indications by incorporating quantitative analysis capabilities. Clinicians can now use companion software to calculate amyloid plaque density, enabling more objective assessments.
Monitoring Anti-Amyloid Therapies
The updated label removes previous restrictions on using Vizamyl to monitor the efficacy of anti-amyloid therapies. It now permits evaluation of amyloid plaque reduction levels to determine whether such treatments can be discontinued.-Fineline Info & Tech
