The First-and-Only Amyloid Imaging Agent with FDA Approval for Color Image Interpretation

Flutemetamol F18 Injection color images provided accurate amyloid detection

In Study 1:
Hign median sentivity and specificity in autopsy standard-of-truth assesment among five independent, blinded image readers.

In Study 2:

• Flutemetamol F18 Injection color image reads demonstrated high inter-reader agreement for visual image interpretation (kappa score 0.83, 95% CI [0.79-086]).

• An intra-reader reproducibility analysis involving two readings for each of 29 duplicate patient images showed: One of the five readers ahd complete agreement for all 29 images, two readers had discordant reads for a single image, and two readers had discordant reads for two images.
• Intra-reader reproducibility for a subgroup of eight images from aMCI patients showed: All five readers had complete agreement for all duplicate images.

*AMCI – Amnestic Mild Cognitive Impairment

DISCOVER AMYLOID IMAGING IN COLOR

• A negative Flutemetamol F18 Injection scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease at the point of image acquisition
• A positive Flutemetamol F18 Injection scan indicates moderate to frequent amyloid neuritic plaques
• Flutemetamol F18 Injection is an adjunct to other diagnostic evaluates

APPROPRIATE SITUATIONS FOR AMYLOID IMAGING

• With persistent or progressive unexplained MCI
• Who satisty core clinical criteria for possible Alzheimer’s disease because pf unclear clinical presentation, either a typical clinical course or an etiologically mixed presentation
• With progressive dementia and a typically early age of onset (usually defined as < 65)

SAFETY OF FLUTEMETAMOL F18 INJECTION

In clinical trials of 761 patients dosed, one experienced a serious hypersensitivity reaction.

• This reaction was accompanied by flushing, dyspnea, and chest pressure
• The reaction occured within minutes of administration of Flutemetamol F18 Injection, and the patient recovered with treatment
• The most commonly reported adverse reactions occured at a rate of <2% and were of mild to moderate intensity
• The recommended dose is 185 MBq (5 mCi) injected intravenously. The adult effective dose is 5.92 mSv